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 5, 2026.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereArizona, Indiana and New Jersey
- Medicine recall Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Theophylline extended-release tablets 400mg, 100-count bottle Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Belsomra (suvorexant) tablets, 10mg, 30 Tablets Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lactated Ringer’s Injection USP, L 7500, 1000mL Excel Container Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL Lack of Processing Controls. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 13, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine D/R, 30 mg, 30 Caps CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector CGMP Deviations - Product was exposed to temperatures outside the product’s labeled storage requirements. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Xolair (omalizumab injection), 75 mg/0.5 ml CGMP Deviations - Product was exposed to temperatures outside the product’s labeled storage requirements. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials CGMP Deviations - Product was exposed to temperatures outside the product’s labeled storage requirements. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Spironolactone Tablets, USP, 25 mg, 100-count bottle Presence of foreign substance: identified as aluminum. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial CGMP Deviations; particulates identified during visual inspection Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial CGMP Deviations; particulates identified during visual inspection Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets 90 mg, 30-count bottles Failed Dissolution Specifications. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sucralfate Tablets, USP 1 gram CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton Sub-Potent Drug: Subpotent assay results during stability testing. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML… Sub-Potent Drug: Subpotent assay results during stability testing. Class IIIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500,… Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only CGMP Deviations; potential temperature excursions due to transit delays Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereFlorida, Ohio and Virginia
- Medicine recall EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only CGMP Deviations; potential temperature excursions due to transit delays Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereFlorida, Ohio and Virginia
- Medicine recall BENLYSTA (belimumab) for injection, 400 mg/20 mL vial CGMP Deviations; potential temperature excursions due to transit delays Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereFlorida, Ohio and Virginia
- Medicine recall Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C,… Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone 200 mg Pellet Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 25 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 25 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass 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.
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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