Recalls by lot
Was my vaccine lot recalled?
72 vaccine recalls and withdrawals listed by FDA (2000–2026), with the lot numbers, reason, class and scope each notice gives. Enter a lot number from a vaccination record to check it.
Read this first. Recalls describe quality, storage, labeling or supply problems in the notice's own words; they are not findings that a vaccine caused harm, and each notice says whether people already vaccinated need to do anything. Distributor recalls cover only the units that distributor shipped. This list may be incomplete: FDA's Enforcement Report has full coverage from 2012, earlier events come from archived FDA notices. If a lot is not listed, your clinic or pharmacy can confirm. Class I is the most serious recall class and Class III the least.
All listed recalls and withdrawals
| Started | Product and recalling firm | Lots | Reason, class and scope | Source |
|---|---|---|---|---|
| 2026-01-26 | IXCHIQ Valneva | All lots (product-wide) | Valneva issued a recall notice for IXCHIQ. FDA had suspended the biologics license in 2025 (see FDA safety communication) and the manufacturer discontinued the product and requested voluntary license revocation. Scope: All distributed product (first distributed Jan 16, 2024) | California Board of Pharmacy recall alert; FDA CBER Permanent Discontinuations page |
| 2025-04-24 | AREXVY, VL RESPIRATORY SYNCYTIAL VIRUS VACCINE 0.5ML (10/BX) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | 5ST2SEDWME, JB27A | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0404-2025 |
| 2025-04-24 | PREVNAR 20, PFS 0.5ML UD (10/CT) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | LX4483, LK6655 | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0401-2025 |
| 2025-04-24 | VAXNEUVANCE, SYR 0.5ML (10/BX) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | Y010032 | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0402-2025 |
| 2025-04-24 | INFANRIX, SYR 25-58-10MG/0.5ML0.5ML (10/PK) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | 5KR3R | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0405-2025 |
| 2025-04-24 | ACTHIB, SDV 10MCG/0.5ML 0.05ML W/DILUENT (5/BX) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | UK208AA | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0406-2025 |
| 2025-04-24 | COMIRNATY 2024, COVID19 MRNA 12+ NEVER FROZEN (10DOSES/BX) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | MD3414 | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0400-2025 |
| 2025-04-24 | TENIVAC, SYR 0.5ML (10/PK) Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | U8492AA | McKesson Medical Surgical is recalling biologic products (Comirnaty, Prevnar 20, Vaxneuvance, Tenivac, Arexy, Infanrix, and ACTHIB) due to severe thunderstorms that caused transit delays resulting in temperature excursions of these cold chain products. Class II Scope: 13 Consignees located in FL, KY, MI, MS, NC, TN, and WV. | FDA Enforcement Report, recall B-0403-2025 |
| 2024-10-25 | PreHevbrio VBI Vaccines | All lots (product-wide) | VBI notified FDA of permanent discontinuance and withdrawal from the U.S. market following company restructuring/bankruptcy, as it could no longer support required systems (recalls, quality complaints, pharmacovigilance); asked that use be suspended and inventory disposed of. The notice does not cite a product quality or safety finding. Scope: All U.S. inventory | California Board of Pharmacy recall alert (reposts manufacturer notice); FDA CBER Permanent Discontinuations page |
| 2024-06-03 | COVID-19 Vaccine, mRNA Pfizer Manufacturing Belgium NV | HN0477, HN0478, LC4370, HM7006 | Pfizer confirmed that four lots of Comirnaty (Covid-19 Vaccine, mRNA), 30 mcg (2023-2024 formula) were shipped and exceeded the required 2 oC - 8 oC refrigerated box qualification for 16 deliveries of these lots potentially impacting the product. Class III Scope: Of the 16 deliveries identified, 8 deliveries were to Alaskan cities (Craig, Talkeetna, Cordova, Homer, Barrow, Fort Yukon, and Kotzebue) and 8 deliveries to U.S. Pacific Island territories were impacted (N. Mariana Islands, Guam, Micronesia, and Palau). | FDA Enforcement Report, recall B-0077-2025 |
| 2024-02-08 | Shingrix Shingles Vaccine Zoster Vaccine Recombinant, Adjuvanted 50 mcg / 0.5 mL Injection… Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | MG5EJ | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0244-2024 |
| 2024-02-08 | IPOL Polio Vaccine Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | W1A101M | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0237-2024 |
| 2024-02-08 | TDVAX Td Vaccine Tetanus and Diphtheria Toxoids Adsorbed Injection Single-Dose Vial 0.5 mL Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | A146A1 | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0243-2024 |
| 2024-02-08 | Twinrix Hepatitis A and Hepatitis B Vaccine Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | H7RF2 | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0239-2024 |
| 2024-02-08 | MenQuadfi Meningitis Vaccine Meningococcal (Groups A, C, Y, and W-135) Conjugate Vaccine, … Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | U7852AB | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0247-2024 |
| 2024-02-08 | Boostrix Tdap Booster Vaccine Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pert… Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | P5SR5 | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0241-2024 |
| 2024-02-08 | ENGERIX-B Hepatitis B Vaccine 20 mcg / mL Injection Prefilled Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | 4T39P | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0240-2024 |
| 2024-02-08 | Adacel Tdap Vaccine Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | 2CA61C1 | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0238-2024 |
| 2024-02-08 | FluMist Quadrivalent 2023 - 2024 Flu Vaccine 10E6.5 - 7.5 FFU Intranasal Sprayer 0.2 mL Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | TJ2944 | McKesson Medical Surgical (MMS) Phoenix, AZ Distribution Center experienced a critical temperature excursion in the Walk-In refrigerator due
to mechanical failures, causing temperatures to fall below the validated range for up to 60 minutes. This incident led to stored medical products being exposed to temperatures as low as 25oF, averaging 28oF over the hour-long period. MMS has initiated a voluntary recall for products negatively impacted by this excursion. Class III Scope: US: TX, AZ, CA | FDA Enforcement Report, recall B-0248-2024 |
| 2023-09-20 | Pneumococcal 15-valent Conjugate Vaccine Merck Sharp & Dohme LLC | W027275, W036242, W037992, W039033, X004289, X005583, X011328, X011332, X011735, X012044 | Merck Sharp & Dohme LLC became aware of Vaxneuvance breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism).
Merck is expanding the scope of the existing recall to include all remaining lots manufactured prior to Corrective and Preventative Action (CAPA) implementation. The recall of the remaining pre-CAPA lots will be made to the wholesale level including CDC. Class II Scope: AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, KS, LA, MA, ME, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY | FDA Enforcement Report, recall B-0023-2024 |
| 2023-07-19 | Pneumococcal 15-valent Conjugate Vaccine Merck Sharp & Dohme LLC | W021510, W027250, W021512, W021637, W028846 | Merck Sharp & Dohme LLC became aware of Vaxneuvance (lots W021510, W027250, W021512, W021637 and W028846) breaking at the syringe flange and/or hub resulting in injury (e.g., skin laceration) during administration. Additionally, breakages were identified by healthcare professionals before administration, while securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a needle safety mechanism). Class II Scope: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY | FDA Enforcement Report, recall B-0573-2023 |
| 2022-09-26 | HEPLISAV-B, PFS Hepatitis B Vaccine (Recombinant), Adjuvanted Mckesson Medical-Surgical Inc. Corporate Office (distributor: applies only to units it shipped) | 937783 | McKesson Medical is recalling HEPLISAV-B because it has experienced temperature excursions and was stored at temperatures lower than those specified on the labeling prior to distribution. Class III Scope: CA | FDA Enforcement Report, recall B-0019-2023 |
| 2021-10-22 | Hepatitis B Vaccine (Recombinant) GlaxoSmithKline Biologicals SA | CP23D | Following a customer complaint received by GSK on August 4, 2021, five syringes from two different cartons (three syringes out of ten in the first carton and two syringes out of ten in the second carton) from Engerix-B Pediatric single dose syringe vaccine lot CP23D had missing labels. The complaint was substantiated by GSK following the return of the syringes missing labels. GSK has decided to voluntarily recall Engerix-B lot CP23D from the market as a precautionary measure to prevent any potential risk of maladministration. Class III Scope: Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NM, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY
International: AP, EU, GU, JP, and VI | FDA Enforcement Report, recall B-0049-2024 |
| 2021-08-09 | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB, Rx only, 5 single dose … Medline Industries Inc (distributor: applies only to units it shipped) | UJ575AAA | Vaccines, in transit greater than allotted timeframe and potentially exceeding the required shipping temperature range, were distributed. Class III Scope: IA, IL, IN, KS, MI, NE, WI | FDA Enforcement Report, recall B-0120-2022 |
| 2021-08-09 | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, 10 sin… Medline Industries Inc (distributor: applies only to units it shipped) | C5788BA | Vaccines, in transit greater than allotted timeframe and potentially exceeding the required shipping temperature range, were distributed. Class III Scope: IA, IL, IN, KS, MI, NE, WI | FDA Enforcement Report, recall B-0123-2022 |
| 2021-08-09 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus an… Medline Industries Inc (distributor: applies only to units it shipped) | UJ528AAA | Vaccines, in transit greater than allotted timeframe and potentially exceeding the required shipping temperature range, were distributed. Class III Scope: IA, IL, IN, KS, MI, NE, WI | FDA Enforcement Report, recall B-0122-2022 |
| 2021-02-10 | Zoster Vaccine Live GlaxoSmithKline Biologicals SA | 9LH3Y | Vaccine, placed in glass vials found to have morphology defects, was distributed. Class II Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0264-2022 |
| 2020-11-06 | Influenza Vaccine, Fluzone, High Dose, Quadrivalent, 0.7 ml, single dose, pre-filled syrin… Medline Industries Inc (distributor: applies only to units it shipped) | UJ541AA | A single lot of Influenza Vaccine, Fluzone, High Dose, Quadrivalent, 0.7 ml, single dose, pre-filled syringe, was shipped outside of the specified storage temperature range. Class II Scope: US: Florida | FDA Enforcement Report, recall B-0062-2021 |
| 2020-10-19 | RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)] Merck Sharp & Dohme Corp. | T007984 | Merck's GARDASIL 9, PNEUMOVAX and RECOMBIVAX HB vaccines, stored at temperatures outside their respective temperature specifications, were subsequently distributed Class II Scope: California | FDA Enforcement Report, recall B-0042-2021 |
| 2020-10-19 | PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) Merck Sharp & Dohme Corp. | S027047 | Merck's GARDASIL 9, PNEUMOVAX and RECOMBIVAX HB vaccines, stored at temperatures outside their respective temperature specifications, were subsequently distributed Class II Scope: California | FDA Enforcement Report, recall B-0041-2021 |
| 2020-10-19 | GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 10 Single-dose 05 mL Prefi… Merck Sharp & Dohme Corp. | R030456 | Merck's GARDASIL 9, PNEUMOVAX and RECOMBIVAX HB vaccines, stored at temperatures outside their respective temperature specifications, were subsequently distributed Class II Scope: California | FDA Enforcement Report, recall B-0040-2021 |
| 2020-10-19 | PNEUMOVAX 23 Merck | S036495 | A limited number of units were stored at temperatures outside specification during shipment by a third-party delivery service to a McKesson facility; Merck advised another dose where a dose from affected units was given. Scope: Only units shipped from McKesson Chino, CA and received/administered on or after Aug 12, 2020 (provider level) | Manufacturer recall letter |
| 2019-06-20 | Cholera Vaccine Live Oral PaxVax, Inc. | 7000014 | Vaxchora, not meeting product specifications, was distributed. Class III Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0469-2020 |
| 2019-02-15 | MENVEO VACCINE, SDV 10-5MG/0.5 MCKESSON MEDICAL (distributor: applies only to units it shipped) | Not stated as lot numbers: 1064517 | Multiple vaccines, lacking assurance of proper storage temperatures, were distributed. Class III Scope: Natiowide | FDA Enforcement Report, recall B-0515-2019 |
| 2019-02-15 | ADACEL TDAP VACCINE, SYR ADLT2MG-2.5MG-5MG/0.5ML (5/BX) MCKESSON MEDICAL (distributor: applies only to units it shipped) | Not stated as lot numbers: 1110687 | Multiple vaccines, lacking assurance of proper storage temperatures, were distributed. Class III Scope: Natiowide | FDA Enforcement Report, recall B-0520-2019 |
| 2019-02-15 | AFLURIA 2018, QUAD SYR 0.5ML (10DOSE/BX) MCKESSON MEDICAL (distributor: applies only to units it shipped) | Not stated as lot numbers: 1087941 | Multiple vaccines, lacking assurance of proper storage temperatures, were distributed. Class III Scope: Natiowide | FDA Enforcement Report, recall B-0521-2019 |
| 2019-02-15 | Bexsero, PFS 0.5 ml (1/BX) MCKESSON MEDICAL (distributor: applies only to units it shipped) | Not stated as lot numbers: 1047589 | Multiple vaccines, lacking assurance of proper storage temperatures, were distributed. Class III Scope: Natiowide | FDA Enforcement Report, recall B-0514-2019 |
| 2019-02-15 | TDVAX, SDV 0.5ML (10/PK) MCKESSON MEDICAL (distributor: applies only to units it shipped) | Not stated as lot numbers: 981867 | Multiple vaccines, lacking assurance of proper storage temperatures, were distributed. Class III Scope: Natiowide | FDA Enforcement Report, recall B-0517-2019 |
| 2019-02-15 | BOOSTRIX, TDAP SYR 2.5-8.5MG/0.5ML 0.5ML (10/PK) SMKLP MCKESSON MEDICAL (distributor: applies only to units it shipped) | Not stated as lot numbers: 772678 | Multiple vaccines, lacking assurance of proper storage temperatures, were distributed. Class III Scope: Natiowide | FDA Enforcement Report, recall B-0516-2019 |
| 2017-07-28 | Bexsero Meningitis Vaccine, 0.5 mL single-dose pre-filled syringes, 60 vials/ 1 each per b… MCKESSON MEDICAL (distributor: applies only to units it shipped) | 159001 | Bexsero Meningitis Vaccine, lacking assurance of proper temperature maintenance during storage, was distributed. Class III Scope: PA, NJ, VA | FDA Enforcement Report, recall B-0886-2017 |
| 2017-07-11 | Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vacc… GlaxoSmithKline Biologicals SA | M16095 | MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM(197) Conjugate Vaccine] Solution for intramuscular injection, associated with a mechanical intervention that is not supported by validation data, was distributed. Class III Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0705-2018 |
| 2015-04-21 | Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) Supplied in Multidose … Sanofi Pasteur, Inc. | UI196AA, UI190AC, UI190AD | Three lots of Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) supplied in Multidose vials, with antigen content that declined below the stability specification limit for two strains prior to product expiry, were distributed. Class III Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0042-16 |
| 2015-04-14 | FLULAVAL QUADRIVALENT ID Biomedical Corp., a subsidary of GSK Biologicals | 2B472, 42N4L, 5AZ7H, 9A3ZM, ZS95Z, A2PK7, AR57J, DR4GF, YF5DT, F45C5, T3J4S, XP4J2, 379MY | Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed. Class III Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0126-16 |
| 2014-10-17 | 1 Single-Dose 0.7 mL Vial STERILE DILUENT For Merck Sharp & Dohme Corp., Live Virus Vaccin… Merck & Co Inc | K009280 | A single lot of Sterile Diluent, with the potential for the lot number and expiry to be missing from the primary label, was distributed. Class III Scope: OH | FDA Enforcement Report, recall B-0300-15 |
| 2013-12-19 | Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Recombinant Vaccine Merck Sharpe & Dohme Corp | J007354 | GARDASIL, one lot with the potential for small glass particles to be present in the vial, was distributed. Class II Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0996-14 |
| 2013-12-02 | Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined NOVARTIS VACCINES AND DIAGNOSTICS S.r.l | M12115 | Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed. Class II Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0214-15 |
| 2013-12-02 | MENVEO Novartis Vaccines and Diagnostics | A12115, X12115 | Higher-than-specified levels of residual moisture within the lyophilized MenA component vial; not expected to impact product quality; no action required for persons previously vaccinated. Class II Scope: Customers asked to check inventory; 8,435 vials | FDA CBER recall notice (archived) + FDA Non-Blood On-Going Recalls page (class) |
| 2013-07-10 | Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined NOVARTIS VACCINES AND DIAGNOSTICS S.r.l | M12118 | Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed. Class II Scope: Multiple U.S. States | FDA Enforcement Report, recall B-1832-13 |
| 2013-07-03 | MENVEO Novartis Vaccines and Diagnostics | A12118, X12118 | Higher-than-specified levels of residual moisture within the lyophilized MenA component vial. Class II Scope: Customers; 70,170 vials | FDA CBER 2013 list (archived) + FDA Non-Blood On-Going Recalls page (class) |
| 2013-06-26 | Hepatitis B Vaccine (Recombinant) Merck Sharpe & Dohme Corp | J001183 | Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed. Class II Scope: Multiple U.S. States | FDA Enforcement Report, recall B-0625-14 |
| 2012-09-25 | Typhoid Vi Polysaccharide Vaccine Sanofi Pasteur, Inc. | E12871, E12881, G04811, G05071, G05081, G11301 | Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed. Class III Scope: Multiple U.S. States | FDA Enforcement Report, recall B-2189-13 |
| 2012-08-01 | Labeled in part: ***Meningococcal***Groups A, C, Y and W-135***Oligosaccharide***Diphtheri… PSS World Medical Shared Services (distributor: applies only to units it shipped) | M10135B | Meningococcal Oligosaccharide Diphtheria Conjugate Vaccine, with lack of assurance of proper temperature maintenance during shipment, was distributed. Class III Scope: TX, MA, AZ and CA | FDA Enforcement Report, recall B-0894-13 |
| 2012-06-12 | Measles, Mumps and Rubella Virus Vaccine Live Merck Sharpe & Dohme Corp | 0851AA | M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)was inadvertently distributed. Class III Scope: Multiple U.S. States | FDA Enforcement Report, recall B-2190-13 |
| 2012-02-28 | FluMist, Influenza Virus Vaccine, Live, Intranasal, each 0.2mL dose is a suspension suppli… MedImmune, LLC | YL2077 | FluMist, Influenza Virus Vaccine, Live Intranasal, lacking assurance of proper temperature manintenance during shipment, was distributed. Class III Scope: Product was distributed within the US to CA, FL and TX. Government account: Department of Defense, Camp Pendleton, CA. | FDA Enforcement Report, recall B-2586-12 |
| 2012-02-10 | Prevnar 13 Pfizer | F73652 | Pfizer initiated the recall when it was determined the lot was formulated and filled with expired serotype 3 conjugate material (FDA list). Scope: Per Pfizer (AP report): recalled from one wholesaler; none distributed to health care providers | FDA CBER 2012 list (event, reason); lot number from secondary news (secondary source only) |
| 2010-12-17 | FLUVIRIN Novartis Vaccines and Diagnostics | 111812P1 | Cracked vial necks leading to broken vials detected in a small number of vials; cracks carry potential risk of compromised sterility. Notice states patients previously vaccinated without problems need no further action such as revaccination. Scope: Consignees asked to check inventory, stop using and return vials from this lot | FDA CBER recall notice (archived) |
| 2010-04-13 | RabAvert Novartis Vaccines and Diagnostics | 458011A, 927011 | Stopper and metal crimp can dislodge from the diluent vial when removing the protective cap (low percentage of diluent vials). Lyophilized vaccine vial not affected; no revaccination required per notice. Scope: Customers asked to return complete kits | FDA CBER notice (archived) |
| 2010-03-22 | Prevnar (PCV7) Wyeth (Pfizer) | E25197, E28211, E37556, E38749 | Potential for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar. Wyeth concluded no health or safety risk, no expected loss of potency, and no need to revaccinate. Scope: Customers asked to contact manufacturer to return product | FDA CBER recall notice (archived) |
| 2010-02-03 | Influenza A (H1N1) 2009 Monovalent Vaccine (prefilled syringes) Sanofi Pasteur | UT023AA, UT023BA, UT023CA, UT023EA, UT023FA | Prefilled syringes; routine stability testing determined that those lots no longer met the potency specification. Scope: Not stated in FDA summary | FDA CBER 2010 Biologics Recalls list (archived); individual notice ucm200665 not archived |
| 2009-12-16 | Influenza A (H1N1) 2009 Monovalent Vaccine (pediatric 0.25 mL) Sanofi Pasteur | UT023DA, UT028CB, UT028DA, UT030CA | Routine testing identified four distributed lots with lower antigen content than the specification limit. FDA and CDC stated there were no safety concerns and did not recommend repeating doses. Scope: Providers asked to stop using and return remaining inventory | FDA CBER recall notice (archived) |
| 2007-12-10 | COMVAX. Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombi… Merck & Co., Inc. | Not stated | Vaccines, with a lack of sterility assurance, were distributed. Class III Scope: The product was shipped to CDC. The product was also shipped to wholesalers, medical facilities, and physicans nationwide. Lot J2438 was shipped to China. | FDA Enforcement Report, recall B-0732-08 |
| 2007-12-10 | Pedvax HIB. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate. The product … Merck & Co., Inc. | Not stated | Vaccines, with a lack of sterility assurance, were distributed. Class III Scope: The product was shipped to CDC. The product was also shipped to wholesalers, medical facilities, and physicans nationwide. Lot J2438 was shipped to China. | FDA Enforcement Report, recall B-0731-08 |
| 2007-03-01 | Pneumovax 23 (Pneumococcal Vaccine Polyvalent) single Dose Vial. 25mcg/ml, 10 vials per pa… AmeriSource Bergen (distributor: applies only to units it shipped) | Not stated | Vaccines, lacking assurance of proper temperatures during transit, were distributed. Class III Scope: The product was shipped to medical facilities in CT, MA, ME, NH, NY, and RI. | FDA Enforcement Report, recall B-1555-07 |
| 2007-02-28 | Recombivax HB (Hepatitis B Vaccine [recombinant]) 40mcg/ml, single dose vials AmeriSource Bergen (distributor: applies only to units it shipped) | Not stated | Vaccines, lacking assurance of appropriate storage temperatures during transit, were distributed. Class III Scope: The products were shipped to medical facilities in CT, MA. NH, NY, and RI. | FDA Enforcement Report, recall B-1576-07 |
| 2007-02-28 | Pedvax HIB (Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate]) 7.5mcg HIB/… AmeriSource Bergen (distributor: applies only to units it shipped) | Not stated | Vaccines, lacking assurance of appropriate storage temperatures during transit, were distributed. Class III Scope: The products were shipped to medical facilities in CT, MA. NH, NY, and RI. | FDA Enforcement Report, recall B-1578-07 |
| 2007-02-28 | COMVAX (Haemophilus b conjugate[meningococcal protein conjugate] and Hepatitis B [recombin… AmeriSource Bergen (distributor: applies only to units it shipped) | Not stated | Vaccines, lacking assurance of appropriate storage temperatures during transit, were distributed. Class III Scope: The products were shipped to medical facilities in CT, MA. NH, NY, and RI. | FDA Enforcement Report, recall B-1579-07 |
| 2007-02-28 | VAQTA (Hepatitis A Vaccine [inactivated]) 50mcg/ml (Adult), single dose vials, 10 vials pe… AmeriSource Bergen (distributor: applies only to units it shipped) | Not stated | Vaccines, lacking assurance of appropriate storage temperatures during transit, were distributed. Class III Scope: The products were shipped to medical facilities in CT, MA. NH, NY, and RI. | FDA Enforcement Report, recall B-1577-07 |
| 2006-10-20 | Fluvirin (Influenza Virus Vaccine). Purified Surface Antigen Vaccine, 2006-2007 Formulatio… Novartis Vaccines | Not stated | Influenza Vaccine, lacking assurance of proper storage temperatures during shipment, was distributed. Class III Scope: The product was shipped to medical facilities nationwide. | FDA Enforcement Report, recall B-0703-07 |
| 2006-05-25 | Decavac Vaccine, 10 x 1 UD Syringe AmeriSource Bergen (distributor: applies only to units it shipped) | Not stated | Vaccines, that were stored under unacceptable temperatures, were distributed. Class II Scope: The product was shipped to a government account in TX | FDA Enforcement Report, recall B-1611-6 |
| 2004-03-31 | IMOVAX Rabies Vaccine***Single Dose Vial (1ml) ***Intramuscular Route*** NDC49281-250-10**… Aventis Pasteur Inc, | Not stated | IMOVAX Rabies Vaccine, manufactured during the same campaign as a bulk lot (not distributed) that failed the test for inactivation, was distributed. Class III Scope: The recalled product was distributed nationwide to all states, along with distribution to District of Columbia and Puerto Rico.
Government accounts that received the product would include the Military, Veteran''s Affairs, CCS, CCS Health Department, Travel Clinics, and federal government. | FDA Enforcement Report, recall B-1675-4 |
| 2002-09-12 | Menomune - A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Com… Aventis Pasteur Inc, | Not stated | Product failed to meet potency specification during stability testing at twelve months. Class III Scope: The product was shipped nationwide to medical facilities, physicians, and retail pharmacies. | FDA Enforcement Report, recall B-1043-3 |
| 2000-09-01 | Diphtheria & Tetanus Toxoids Adsorbed Bioport Corp. | Not stated | Products were manufactured during a period where microbiological control of the manufacturing operation could not be assured. Class II Scope: Florida, Massachusetts and Michigan. | FDA Enforcement Report, recall B-1993-4 |
FDA Enforcement Report entries retrieved 2026-10-28; search them yourself on FDA's Enforcement Report. Download: lot_recalls.json.
Vaccine shortages
FDA's list of current shortages of CBER-regulated products (updated 28 September 2026) lists BCG vaccine for tuberculosis prevention as the only vaccine in shortage; it lists no MMR, Tdap/Td or pneumococcal polysaccharide vaccine shortage. CDC's vaccine shortage page reported no shortages when last updated (27 September 2024). Products permanently discontinued include IXCHIQ (January 2026) and PreHevbrio (November 2024). Sources: FDA current shortages · FDA permanent discontinuations · CDC shortages and delays.
Common questions
Was my vaccine lot recalled?
Type the lot number from your vaccination record into the box on this page. It checks the lot numbers listed in FDA Enforcement Report entries for vaccine products and in FDA and manufacturer recall notices. A lot that is not listed may still have been part of a recall this list does not cover; your clinic or pharmacy can confirm.
What does a vaccine recall mean?
A recall removes product from distribution because of a problem the notice describes, such as low potency near expiry, a container or syringe defect, a labeling error or a storage-temperature excursion. Each notice says whether people who already received a dose need to do anything; many say no revaccination is needed, some advise another dose.
What is a distributor-level recall?
Some recalls are started by a distributor (for example after a refrigeration failure at one warehouse). They cover only the units that distributor shipped, not every dose with that lot number.
VAERS reports for a lot: lots by vaccine and manufacturer · search any lot.
Built 2026-10-28. Not medical advice.