Recall
FDAHealthMay 22, 2025

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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 22, 2025

USA Nationwide.

What's affected?

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
UPC
0195515048866
Lot code
AEF124004A

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 4,608 bottles.

View original FDA notice →

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