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 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube,… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D.… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0% CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21% CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC,… CGMP Deviations Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Puerto Rico and Washington
- Medicine recall Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle Failed Impurities/Degradation Specifications: Due to levels of ‘Diester Impurity’ exceeding the specification limit. Class IIIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded… Subpotent Drug Class IIIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle Failed Dissolution Specifications Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%) CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DermaFungal, Antifungal Cream with 2% Miconazole Nitrate CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DermaSarra, Camphor 0.5%, External Analgesic, 222 mL CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GelRite Instant Hand Sanitizer, Alcohol 65% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hand-E-Foam, Benzethonium Chloride 0.20% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lantiseptic, Dry Skin Therapy, Lanolin USP 30% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lantiseptic, Skin Protectant, Lanolin USP 30% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall McKesson Skin Protectant, Lanolin USP CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PeriGuard Ointment, Petrolatum 49.9% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Renew Skin Repair Cream, Dimethicone 1.5% CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall San-E-Foam, Alcohol 67%, 1000 mL CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedNov 26, 2025ClassClass IIStatusOngoingWhereMissouri
- Medicine recall POTASSIUM CHLORIDE Inj., 20 mEq total Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall POTASSIUM CHLORIDE Inj., 10 mEq total Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when… Subpotent drug; Clavulanate Potassium component Class IIFDA’s classNov 12, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereCalifornia, Mississippi and Ohio
- Medicine recall clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Acetaminophen 500mg Caffeine 65mg caplets Labeling: Label Mix-up. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton Lack of Assurance of Sterility. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNew Jersey
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count… CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. 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, 100 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, 2 mg, 100 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
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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