Aurobindo Pharma USA Inc: Drug Recall

Recall #D-0471-2025 · 05/22/2025

Class II: Risk

Recall Details

Recall Number: D-0471-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Aurobindo Pharma USA Inc
Status: Ongoing
Date Initiated: 05/22/2025
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,608 bottles

Reason for Recall

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

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

Distribution Pattern

USA Nationwide.

Other Recalls by Aurobindo Pharma USA Inc

Class II: Risk 12/06/2024

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I: Dangerous 07/11/2024

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

View all recalls by Aurobindo Pharma USA Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.