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Recall Observatory FDA recall evidence

Drug 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

D-0471-2025

May 22, 2025

Class II

Product summary

Firm
Aurobindo Pharma USA Inc
Event
Event 96907
Status
Ongoing
Classification
Class II
Quantity
4,608 bottles
Official record key
drug-enforcement:D-0471-2025

Official wording

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

Code information: Lot#: AEF124004A, Exp date 08/31/2026

Distribution pattern: USA Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations