US Drug Recall Register
Class II · Moderate risk Ongoing Initiated May 22, 2025 (16 months ago)

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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 firm
Aurobindo Pharma USA Inc
NDC code
72288-405-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0471-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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