PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: June 25, 2025 Initiated: May 22, 2025 #D-0471-2025

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).

Details

Recalling Firm
Aurobindo Pharma USA Inc
Units Affected
4,608 bottles
Distribution
USA Nationwide.
Location
East Windsor, NJ

Frequently Asked Questions

What product 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. Recalled by Aurobindo Pharma USA Inc. Units affected: 4,608 bottles.
Why was this product recalled?
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Which agency issued this recall?
This recall was issued by the FDA Drug on June 25, 2025. Severity: Moderate. Recall number: D-0471-2025.