D-0471-2025 Class II Ongoing

Recalled by Aurobindo Pharma USA Inc — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
June 25, 2025
Initiation Date
May 22, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,608 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

USA Nationwide.

Code Information

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