Acetaminophen is a widely used over-the-counter pain reliever and fever reducer. We track every FDA enforcement recall involving Acetaminophen (Tylenol) — 50 recalls in our database, including 14 active.
Add Acetaminophen to your medicine cabinet and we’ll email you the moment the FDA issues a new recall — before your pharmacy calls. Free forever, no credit card.
SpecGx, LLC — Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall D-0255-2026
SpecGx, LLC — Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall D-0254-2026
Kenvue Brands LLC — Defective Container
Recall D-0121-2026
Baxter Healthcare Corporation — Discoloration
Recall D-0596-2025
Aurobindo Pharma USA Inc — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Recall D-0471-2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations
Recall D-0347-2025
LNK International, Inc. — CGMP Deviations: Released product should have been rejected.
Recall D-0115-2025
Denison Pharmaceuticals, LLC — Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recall D-0034-2025
Showing 8 of 50. See all Acetaminophen recalls.
This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.
The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Acetaminophen recall is issued.
Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.
Yes — weekly recall alert digests are free forever, with no credit card required. See pricing.