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
Testosterone
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Doxazosin Tablets
Class IIITablets/Capsules Imprinted with Wrong ID
Unichem Pharmaceuticals USA Inc. · Jan 21, 2026
Bisoprolol Fumarate and Hydrochlorothiazide tablets
Class IIcGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Unichem Pharmaceuticals USA Inc. · Jan 21, 2026
Children's Healthcare of Atlanta
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanit…
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Cleansing Towelette (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Antimicrobial Alcohol Hand Wipe
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5…
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%)…
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%)
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 pack…
Class IICGMP Deviations
ACME UNITED CORPORATION · Jan 20, 2026
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 Repackag…
Class IISubpotent Drug
Specialty Process Labs LLC · Jan 16, 2026
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,…
Class ITemperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
McKesson · 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 Eye Relief Re…
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
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.