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 Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DOBUTamine Injection, USP, 250 mg/20 mL Discoloration; discolored solution from cracked vials Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 500 mL Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TESTO-200, Testosterone Cypionate Inj Marketed Without an Approved NDA/ANDA Class IIFDA’s classJul 2, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNew Jersey and New York
- Medicine recall Acetaminophen Tablets, 325 mg, 100-count bottles cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IStatusCompletedWhereNationwide
- Medicine recall UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IStatusCompletedWhereNationwide
- Medicine recall Celecoxib Capsules, 200 mg, 500-count bottle Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Celecoxib Capsules, 200 mg, 50 Capsules Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorthalidone Tablets, USP, 25 mg, 50 Tablets Failed Dissolution Specifications Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during… Class IIIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2025ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall ELECTRO BUZZ, Dietary Supplement, 10 capsules per box Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Male Ultra Pro, Unleash Your Force 2, 10 capsules per box Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed) Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed) Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP 112 mcg Presence of a foreign substance: black hair found embedded in tablet. Class IIIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 18, 2025ClassClass IIStatusCompletedWhereIllinois, Mississippi and Pennsylvania
- Medicine recall Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules cGMP deviations Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fluoxetine Tablets, USP, 20 mg, 30-count bottle CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Fluoxetine Tablets, USP, 20 mg, 28-count Carton CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL Defective Container: This recall is being initiated due to a leaking unit stored horizontally. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle Failed Impurities/Degradation Specifications Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC… CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC… CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets USP 12.5 mg, 500-Count bottle CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets USP 25 mg, 500 -Count bottle CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle OOS results reported for the Dissolution (by UV) test. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and… Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain… CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall CURA HONGOS, Antifungal Cream, Clotrimazole 1% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External… CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
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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