Class IIOngoing

Acetaminophen Tablets recall

FDA recall D-0471-2025 · initiated May 22, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Details

Product: Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Recalling company: Aurobindo Pharma Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide.
Initiated: May 22, 2025
FDA report date: Jun 25, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0471-2025 ↗

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