FDA recall D-0471-2025

Aurobindo Pharma USA Inc · Class II · 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

Reason for recall

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

Distribution

USA Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-05-22
Report date
2025-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2025