US Drug Recall Register
Class II · Moderate risk Completed Initiated May 22, 2023 (3 years ago)

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

What was recalled

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

Recalling firm
Aurobindo Pharma USA Inc.
NDC code
0363-9947-35
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0765-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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