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
Arize Herbal Dietary Supplement
Class IMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World · Feb 6, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Super Chill Products · Feb 5, 2024
To the Moon Capsules
Class IMarketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Integrity Products · Feb 1, 2024
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box…
Class IMarketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Integrity Products · Feb 1, 2024
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Class IChemical Contamination; presence of benzene.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Feb 1, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Neptune Resources, LLC · Jan 12, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Neptune Resources, LLC · Jan 12, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Neptune Resources, LLC · Jan 12, 2024
Zenzedi (Dextroamphetamine Sulfate) CII Tablets
Class ILabeling: Label Mix-up
Azurity Pharmaceuticals, Inc. · Jan 4, 2024
Showing 9 of 129 Class I recalls (1,769 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.