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
Vista Tears Polyethylene Glycol 400 0.4% w/v
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Dec 31, 2025
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Dec 31, 2025
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited · Dec 31, 2025
Icosapent Ethyl capsules
Class IISubpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Zydus Pharmaceuticals (USA) Inc · Dec 30, 2025
Fluocinolone Acetonide Solution Topical Solution USP
Class IIIFailed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC · Dec 30, 2025
Ondansetron Orally Disintegrating 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.
Glenmark Pharmaceuticals Inc., USA · Dec 30, 2025
TPN bag (patient specific)
Class IIIncorrect Product Formulation: product did not contain insulin as listed in the label.
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles · Dec 27, 2025
Benadryl, 25'S 2PK Box, UPC 815556020316
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Alka Seltzer
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
DAYQUIL COLD & FLU
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
PEPCID COMPLETE
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Bayer 2Pk- 25 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Claritin, 20 Count, UPC: 655708016305
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
NYQUIL COLD & FLU -32CT/2PK
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
LIQUID NYQUIL a) regular
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Carmex a) jar
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
PEPTO BISMOL 32CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Advil a) Ibuprofen
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Halls Cough Drops a) BAGS
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
CHILDREN NYQUIL
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Deodorant: a) Axe
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Toothpaste: a) COLGATE
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
EXCEDRIN 2'S DISP.- 30 CT
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
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
MOTRIN 2'S DISP.- 50CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
TUMS a) Assorted
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Haleon US Holdings LLC · 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 Petroleum Jelly
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
Rheumacare capsules
Class ICGMP Deviations: product found to contain lead.
HANDELNINE GLOBAL LLC · Dec 22, 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
Diclofenac Sodium Topical Gel
Class IIIFailed PH Specifications
Cipla USA, Inc. · 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
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.