Medicines, 2022
Shortlist up to four to read them side by side.
1,349 medicine recalls FDA’s Enforcement Report published in 2022, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ Incorrect/Undeclared Excipient: Product contains alcohol Class IIIFDA’s classMay 4, 2022in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedMay 4, 2022ClassClass IIIStatusTerminatedWhereIllinois
- Medicine recall Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC:… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereAlaska and Pennsylvania
- Medicine recall Losartan Potassium Tab CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Florida and Indiana named
- Medicine recall Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials Subpotent Drug: Out of specification for assay. Class IIIFDA’s classMay 4, 2022in FDA’s Enforcement ReportAlabamathe one state its words name PublishedMay 4, 2022ClassClass IIIStatusTerminatedWhereAlabama
- Medicine recall Zonisamide Capsules USP, 25 mg cGMP deviations Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Zonisamide Capsules, USP, 50 mg cGMP deviations Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Zonisamide Capsules, USP, 100 mg cGMP deviations Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Lidocaine 2.5% and Prilocaine 2.5% Cream, USP cGMP Deviations Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QM-2 Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall T-105, Papaverine 30mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula F9, Papaverine 0.9mg/ml CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AT-6, Papaverine 40mg/ml CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AT-1, Papaverine 8mg/ml CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NB-243, Papaverine 30mg/ml CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall T-106, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall T-101, Papaverine 17.65 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SB-4, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SB-5, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SB-6, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ST-1, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ST-2, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QM-3, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QM-4, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RE-1, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RE-2, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BIMIX-3, Papaverine 30 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FA, Papaverine 20 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall T-50, Papaverine 8 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula F2, Papaverine 9 mg/mL CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate 200 mg/mL (in Grapeseed Oil) CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate 200 mg/mL, (in Sesame Oil) CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial Failed Reconstitution time Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100) Labeling: Missing label on the vial FDA Class I, its most serious class Class IFDA’s class (needs attention)May 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rifampin for Injection, USP, 600 mg/vial, One Vial per carton Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ARA-290 (Cibinetide Acetate) 6 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BPC-157 2 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ipamorelin Acetate/Sermorelin Acetate Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.