Medicines, 2025
Shortlist up to four to read them side by side.
765 medicine recalls FDA’s Enforcement Report published in 2025, 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.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Indomethacin Extended-Release Capsules, 75mg, 60-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lacosamide Tablets, 100mg , 60-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90) CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC#… CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Teriflunomide Tablets, 14mg, 30-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ranolazine Extended-Release Tablets 1000mg, 60-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP 12.5 mg, 500-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lacosamide Tablets, 50mg, 60-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prochlorperazine Maleate Tablets, 10mg, 100-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rosuvastatin Tablets 40mg, 30-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC#… CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lacosamide Tablets 150mg, 60-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC#… CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Naproxen Sodium Tablets, USP, 550mg, 100-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b).… CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container… Presence of Particulate Matter Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methocarbamol Injection USP 1,000 mg/10 mL Lack of Assurance of Sterility: Media fill with bacterial contamination Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial Lack of Assurance of Sterility: Media fill with bacterial contamination Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial Lack of Assurance of Sterility: Media fill with bacterial contamination Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial Lack of Assurance of Sterility: Media fill with bacterial contamination Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial Lack of Assurance of Sterility: Media fill with bacterial contamination Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. Chemical contamination: Presence of benzene Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%) Chemical contamination: Presence of benzene Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP 10 mg CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, Florida, Indiana, Kentucky, Louisiana, Minnesota, Mississippi, North Dakota, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Vermont and Wisconsin named
- Medicine recall Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. Class IIIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL… Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. Class IIIFDA’s classApr 9, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 9, 2025ClassClass IIIStatusOngoingWhereFlorida and New York
- Medicine recall Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle Failed dissolution specifications: lower than specifications Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Voriconazole Tablets, 50 mg cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30 mg CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP 100 mg CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS Presence of Foreign Tablets/Capsules. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton Presence of foreign substance: Presence of Benzene. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton Presence of foreign substance: Presence of Benzene. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall fentaNYL Citrate PF 200 mcg/100 mL Lack of Assurance of Sterility Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate PF 200 mcg/100 mL Lack of Assurance of Sterility Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate PF 200 mcg/100 mL Lack of Assurance of Sterility Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ Failed stability specifications: during routine stability monitoring quality concerns were identified. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP… Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IStatusOngoingWhereNationwide
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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