Cipla USA, Inc.: Drug Recall
Recall #D-0226-2026 · 11/14/2025
Class II: Risk
Recall Details
- Recall Number
- D-0226-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Cipla USA, Inc.
- Status
- Ongoing
- Date Initiated
- 11/14/2025
- Location
- Warren, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,576 bottles
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product Description
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Distribution Pattern
Nationwide in the US
Other Recalls by Cipla USA, Inc.
- Class II: Risk 01/02/2026
- Class III: Low Risk 12/22/2025
- Class II: Risk 11/14/2025
- Class II: Risk 11/14/2025
- Class II: Risk 10/24/2025
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.