FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
Wegovy (semaglutide) Injection
Class IIPresence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc. · Dec 19, 2025
traZODONE Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals (USA) Inc · Dec 19, 2025
Dexamethasone Moxifloxacin
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Dec 18, 2025
Dexamethasone Moxifloxacin Ketorolac
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Dec 18, 2025
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Dec 18, 2025
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG)
Class IILack of Assurance of Sterlity
CareFusion 213, LLC · Dec 17, 2025
Fesoterodine Fumarate
Class IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited · Dec 16, 2025
Oxycodone and Acetaminophen CII Tablets USP
Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Dec 16, 2025
Oxycodone and Acetaminophen CII Tablets USP
Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Dec 16, 2025
MR. 7 SUPER 700000 capsules
Class IMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
StuffbyNainax · Dec 15, 2025
Glycopyrrolate Oral Solution
Class IIIFailed Impurities/Degradation Specifications
NOVADOZ PHARMACEUTICALS LLC · Dec 15, 2025
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension
Class IIPresence of particulate matter: potential presence of metal particulates in the product.
Merck Sharp & Dohme LLC · Dec 12, 2025
ReBoost Nasal Spray
Class IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Medinatura New Mexico, inc. · Dec 12, 2025
Merck Emend (aprepitant) for oral suspension
Class IIPresence of particulate matter: potential presence of metal particulates in the product.
Merck Sharp & Dohme LLC · Dec 12, 2025
ClearLife Allergy Nasal Spray
Class IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Medinatura New Mexico, inc. · Dec 12, 2025
Ciclopirox Shampoo
Class IIFailed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
SUN PHARMA /TARO · Dec 9, 2025
ORL Kids Natural Toothpaste
Class IIcGMP Deviations
Signature Formulations, LLC · Dec 8, 2025
ORL Kids Mouthwash
Class IIcGMP Deviations
Signature Formulations, LLC · Dec 8, 2025
Clindamycin Phosphate USP
Class IIIFailed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 26, 2025
Cisatracurium Besylate Injection USP
Class IIISubpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Cisatracurium Besylate Injection USP
Class IIISubpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL)
Class IIICorrect Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Winder Laboratories, LLC · Nov 26, 2025
Cisatracurium Besylate Injection USP
Class IIISubpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Baclofen Tablets USP
Class IIPresence of Foreign Tablets/Capsules
Golden State Medical Supply Inc. · Nov 26, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Nov 24, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Nov 24, 2025
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Class IIICross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Glenmark Pharmaceuticals Inc., USA · Nov 21, 2025
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth…
Class IIIncorrect Product Formulation
Fagron Compounding Services · Nov 20, 2025
Nebivolol Tablets
Class IIICross Contamination with Other Products
Glenmark Pharmaceuticals Inc., USA · Nov 18, 2025
Ondansetron ODT Tablets
Class IIDefective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Preferred Pharmaceuticals, Inc. · Nov 17, 2025
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc. · Nov 14, 2025
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc. · Nov 14, 2025
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc. · Nov 14, 2025
Ganirelix Acetate Injection
Class IIFailed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Lupin Pharmaceuticals Inc. · Nov 13, 2025
Walgreens Saline Nasal Spray WITH XYLITOL
Class IIMicrobial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Medical Products Laboratories, Inc. · Nov 12, 2025
Varenicline Tablets
Class IIISub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Dr. Reddy's Laboratories, Inc. · Nov 11, 2025
Carton label: Testosterone Gel 1%
Class IIIDefective Container - A defect in the side-seal which allows leakage of product.
Teva Pharmaceuticals USA, Inc · Nov 7, 2025
Famotidine Injection
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Fresenius Kabi USA, LLC · Nov 6, 2025
Sertraline Hydrochloride Tablets USP
Class IIDefective container - seal not adhering to bottles
Lupin Pharmaceuticals Inc. · Nov 5, 2025
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corpo…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Showing 40 of 1,769 recalls tracked.
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.