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 Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prazosin Hydrochloride, Capsules, USP, 1 mg CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prazosin Hydrochloride, Capsules, USP, 2 mg CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prazosin Hydrochloride, Capsules, USP, 5 mg CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01) CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01) CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01) CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01) CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01) CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25) CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride… Presence of Particulate Matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide Injection, 12.5/5mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall Semaglutide Injection, 10 mg/4 mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall Semaglutide Injection, 6mg/2.4mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall Semaglutide Injection, 8mg/3.2mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall Semaglutide Injection, 2.5mg/1mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall Semaglutide Injection, 5 mg/2 mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall Tirzepatide Injection, 27 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereTexas and Utah
- Medicine recall TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each Defective Container Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Illinois, Indiana and Ohio named
- Medicine recall Sting Relief Swabs, First Aid Only, 10 Swabs per box Product Mix-up Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide Pellet CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide Pellet CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone / Triamcinolone Acetonide Pellet CGMP Deviations: Potential presence of metal particulate matter Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 Labeling: Not Elsewhere Classified Class IIIFDA’s classNov 5, 2025in FDA’s Enforcement ReportAlabamathe one state its words name PublishedNov 5, 2025ClassClass IIIStatusOngoingWhereAlabama
- Medicine recall Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class IIIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class IIIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class IIIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class IIIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall 0.9% SODIUM CHLORIDE Injection, USP, 100 mL Lack of Assurance of Sterility: Potential for flexible container leaks. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C,… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 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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