Medicines, 2025
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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 Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit Presence of particulate matter: potential presence of metal particulates in the product. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton Presence of particulate matter: potential presence of metal particulates in the product. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP) Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP) Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cook-Walte, Carbocaine 3% Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL Defective container: cracked/broken cartridges Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Baclofen Tablets USP, 10 mg, 1000-count bottles Presence of Foreign Tablets/Capsules Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cisatracurium Besylate Injection USP, 10 mg/5 mL* Subpotent product:out of specification assay results observed during long term stability testing. Class IIIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton Subpotent product:out of specification assay results observed during long term stability testing. Class IIIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton Subpotent product:out of specification assay results observed during long term stability testing. Class IIIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged… Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Ciclopirox Shampoo, 1%, 120 mL Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton Failed stability specifications: Out of specification for hardness test Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton Failed stability specifications: Out of specification for hardness test Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Varenicline Tablets, 1mg, 56 Tablets Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2’ needle Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereFlorida, Massachusetts, Michigan and Ohio
- Medicine recall Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL… Incorrect Product Formulation Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nebivolol Tablets, 20 mg, 90 Tablets Cross Contamination with Other Products Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Morphine Sulfate Oral Solution 100 mg / 5 mL Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles Defective container - seal not adhering to bottles Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton Failed Stability Specifications: Observed OOS results: eg results for colour index Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets Defective Container - A defect in the side-seal which allows leakage of product. Class IIIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe Class IIIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume CGMP Deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 10, 2025ClassClass IIStatusOngoingWhereMissouri
- Medicine recall Lanashield Skin Barrier, 4 oz. cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dynashield Skin Protectant cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Wecare Enema, 4.5 Fl Oz/133mL cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dynagel, Moisturizing Wound Hydrogel cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall WeCare, Zinc Oxide Ointment cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dynashield, 4 oz cream cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nivagen, Zinc Oxide Ointment cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 % cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Globe Clotrimazole Cream, USP, 1 % cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Globe Clotrimazole Cream USP, 1 % Antifungal Cream cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Wecare Calasoothe cGMP deviations Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedDec 10, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Famotidine Injection, USP, 20 mg per 2 mL Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 3, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Hawaii and Puerto Rico named
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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