Medicines, 2019
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2,152 medicine recalls FDA’s Enforcement Report published in 2019, 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 5, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack… Defective delivery system; product is not foaming or is coming out as liquid. Class IIIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl 2% 5 mL, Syringe Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Petroleum jelly (White Petrolatum) USP 100% Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mirtazapine Tablets, USP, 15 mg, 500-count tablets Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine… Microbial contamination of non-sterile product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regular Strength Zantac 75 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Maximum Strength Zantac 150 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regular Strength Zantac 150 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cool Mint Maximum Strength Zantac 150 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Maximum Strength Zantac 150 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regular Strength Zantac 75 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regular Strength Zantac 150 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regular Strength Zantac 75 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regular Strength Zantac 75 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Zantac 150 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Zantac 75 mg CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL 500 mcg/250 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 500 mcg/250 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 500 mcg/250 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1500 mcg/30 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 500 mcg/250 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2500 mcg/250 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 400 mcg/200 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1000 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 100 mcg/2 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2750 mcg/55 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 250 mcg/5 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 400 mcg/200 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2000 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 400 mcg/200 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1000 mcg/20 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1250 mcg/250 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 800 mcg/200 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2500 mcg/50 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1500 mcg/30 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1000 mcg/100 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 550 mcg/55 mL Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluphenazine Decanoate Injection USP 125mg/5mL Discoloration; Hazy solution found in one vial instead of a clear solution. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL Sub Potent Drug: Out of Specification (OOS) Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL Crystallization: Presence of visible particulate matter. Class IIIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIIStatusTerminatedWhereNationwide
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.”
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