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 6, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Gel Hand Sanitizer (Ethyl Alcohol 70%) Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Advanced Gel Hand Sanitizer (Ethyl alcohol 62%) Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Blue Fusion Capsules, 1- count blister pack Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets Subpotent Drug. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Docusate Sodium, 100mg softgels Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles Defective Container: Repetitive complaints received indicating pump not working. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HYDROmorphone HCl 1 mg Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam Benzodiazepine 50 mg/50 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 500 mcg Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Injectable Solution 1 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 400 mcg Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 1 mg Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection Solution 5 mg/5mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate 0.6 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 800 mcg Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Esmolol HCl Injectable Solution 100 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin 10 Units/10 mL 10 Units Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin 5,000 Units/5mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 30 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 1,200 mcg Lack of Assurance of Sterility Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP 320 mg, 90 count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets USP 40 mg, 30 count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets USP 80 mg, 90 count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets USP 160 mg, 90 count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereFlorida, New Jersey and New York
- Medicine recall Losartan Potassium Tablets USP, 25 mg CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium Tablets USP, 50 mg CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium Tablets USP, 100 mg CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 50 mg 50 Tablets CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP 160 mg, 100 Tablets CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereArkansas, California, Georgia, Indiana and Maryland
- Medicine recall Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereArkansas, California, Georgia, Indiana and Maryland
- Medicine recall Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereArkansas, California, Georgia, Indiana and Maryland
- Medicine recall Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC:… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia and Indiana
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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