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 Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ritussin DM Double Strength, 4 FL cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gericare Geri-Tussin DM, 16 FL OZ cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MONSEL’S (Ferric Subsulfate) Solution, 8 mL amber glass bottle Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring… Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle Failed Dissolution Specifications. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Milrinone Lactate Injection 200 mcg Lack of Assurance of Sterility: Bags have the potential to leak. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medicine recall Milrinone Lactate Injection 200 mcg Lack of Assurance of Sterility: Bags have the potential to leak. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medicine recall Fluorouracil Injection, USP, 5 g / 100 mL Presence of Particulate Matter; glass particulates FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only Labeling: Missing label; Product complaints reported missing bottle label. Class IIIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP 50 mg 90 tablets CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets 50 mg 1000 Tablets, USP CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium, 50 mg tablets, 30 count bottle CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium, 50 mg tablets, 90 count bottle CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium, 50 mg tablets, 1000 count bottle CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium, 100 mg tablets, 90 count bottle CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP. 50 mg CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles GMP Deviations: Potential cross contamination due to cleaning procedure failure. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Testosterone Cypionate 200 mg/mL Sesame Oil Injection Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Prostaglandin 20 mcg/mL/Procaine 0.1% Injection Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Methylcobalamin 1 mg/mL Injection, 8 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Methylcobalamin 10 mg/mL Injection, 5.4 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Serum Tears 20% Eye Drops PF Solution Lack of Assurance of Sterility. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIdaho and Washington
- Medicine recall Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. Class IIIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. Class IIIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of… Defective Container; actuator may improperly function and affect dose delivery. Class IIIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl Incorrect Product Formulation; Firm’s customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate PF INJ, 0.8 mg/2 mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass 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.”
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