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
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or…
Class IISubpotent Drug
Specialty Process Labs LLC · Jan 16, 2026
methylprednisolone tablets
Class IILabeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Greenstone Llc · Jan 15, 2026
Oxycodone Hydrochloride Tablets
Class IIDefective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Amerisource Health Services LLC · Jan 14, 2026
Isotretinoin Capsules
Class IISuperpotent and Subpotent
Teva Pharmaceuticals USA, Inc · Jan 12, 2026
Isotretinoin Capsules
Class IISuperpotent and Subpotent
Teva Pharmaceuticals USA, Inc · Jan 12, 2026
Furosemide Tablets
Class IIPresence of Foreign Substance
Graviti Pharmaceuticals Private Limited · Jan 10, 2026
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
Class IIcGMP deviations.
Encon Safety Products Co · Jan 6, 2026
Lanreotide Injection
Class IIPresence of Particulate Matter.
Cipla USA, Inc. · Jan 2, 2026
CHNaO Fluorescein Sodium Ophthalmic Strips
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
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Relief…
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
Rosuvastatin Tablets
Class IIOut of specification for dissolution.
AvKARE · Dec 31, 2025
Levothyroxine Sodium Tablets
Class IIProduct Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Alvogen, Inc · Dec 31, 2025
Vista Gonio Eye Lubricant
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
Vista Gel Hypromellose USP 0.3% 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
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
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
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.