FDA Drug · D-0471-2025

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot#: AEF124004A, Exp date 08/31/2026

Recalling firm: Aurobindo Pharma USA Inc, East Windsor, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 4,608 bottles
Distribution: USA Nationwide.
Recall initiated: May 22, 2025
Classified: June 17, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0471-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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