FDA Recall D-0471-2025

Aurobindo Pharma USA Inc · East Windsor, NJ

Class II Ongoing 357 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot#: AEF124004A, Exp date 08/31/2026

Quantity: 4,608 bottles

Reason for recall

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

Recall record

Recall number: D-0471-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: USA Nationwide.
Recall initiated: 2025-05-22
Classified by FDA Center: 2025-06-17
FDA published: 2025-06-25
Recalling firm: Aurobindo Pharma USA Inc
Firm location: East Windsor, NJ

Drug identification

Brand name(s): AMAZON BASIC CARE ACETAMINOPHEN
Generic name(s): ACETAMINOPHEN
Manufacturer(s): Amazon.com Services LLC
NDC(s): 72288-405
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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