Aurobindo Pharma USA Inc: Drug Recall

Recall #D-0077-2025 · 11/07/2024

Class II: Risk

Recall Details

Recall Number: D-0077-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Aurobindo Pharma USA Inc
Status: Ongoing
Date Initiated: 11/07/2024
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 102576 bottles

Reason for Recall

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Product Description

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Distribution Pattern

USA Nationwide

Other Recalls by Aurobindo Pharma USA Inc

Class II: Risk 05/22/2025

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