Medicines
Shortlist up to four to read them side by side.
704 medicine recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
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The list
- Medicine recall Levocarnitine Injection, USP, 1 g/5 mL Labeling: Missing Label Class IIIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Optase Dry Eye Intense Drops (Glycerin 0.2%) Lack of Assurance of Sterility Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate injectable Solution cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate Injectable Solution cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ketamine Hydrochloride Injectable Solution, 50mg/ml cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate Injectable Solution cGMP deviations. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%) Failed PH Specifications Class IIIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle Discoloration: Firm received five (5) complaints stating that, “Tablets discolored darker than normal and have lighter-colored spots.” Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Furosemide Tablets, USP, 80 mg, 100 Tablets bottles CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ Lack of Assurance of Sterility Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Premier, Monsel’s, Ferric Subsulfate Solution, 8 mL bottles Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). Class IIIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sterile Water for Injection USP, 3000 mL bags Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DEXTROSE INJECTION USP, 70%, 2000 mL bags Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LACTATED RINGER’S IRRIGATION, 3000 mL bags, Sterile, Ex only, B Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Claravis (isotretinoin capsule, USP), 10 mg Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl Chemical contamination: Presence of benzene Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml Chemical contamination: Presence of benzene Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl Chemical contamination: Presence of benzene Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl Chemical contamination: Presence of benzene Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor,… This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor,… This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag This recall is being initiated following FDA’s recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials Lack of Assurance of Sterility Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 22, 2026ClassClass IIStatusOngoingWhereOregon
- Medicine recall Fluocinonide, USP, 0.05% Cream, 15g tube Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fluocinonide, USP, 0.05% Cream, 30g tube Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
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.
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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