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
TUMS a) Assorted
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Aleve 1's, 60 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Petroleum jelly: a) Vaseline
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Personal Care
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Swan, White Clear Alcohol, 50%, 16oz, 12 count
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
EXCEDRIN MIGRAINE 2'S- 25 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
LIQUID DAYQUIL 12/8oz
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
TYLENOL a) 500 MG.
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Sterile Water for Irrigation
Class IIPresence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Baxter Healthcare Corporation · Dec 22, 2025
INON ACE Antacid tablets (magnesium aluminosilicate
Class IIFailed Disintegration Specifications: above the time expected.
Sato Pharmaceutical Co., Ltd · Dec 19, 2025
Wegovy (semaglutide) Injection
Class IIPresence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc. · Dec 19, 2025
Wegovy (semaglutide) Injection
Class IIPresence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk 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
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
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
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
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
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
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical…
Class IIIncorrect Product Formulation
Fagron Compounding Services · Nov 20, 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
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…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Lidocaine HCI 2% and Epinephrine 1:100
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection…
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Globe Clotrimazole Cream USP
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Pharmaceuticals, Inc.…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Showing 40 of 1,576 Class II recalls (1,895 tracked in total).
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.