D-0226-2026 Class II Ongoing
FDA drug recall D-0226-2026 was initiated by Cipla USA, Inc. on November 14, 2025 and is designated Class II. Reason for recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. The recall status is ongoing. Affected quantity: 12,576 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 17, 2025
- Initiation Date
- November 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,576 bottles
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
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Distribution Pattern
Nationwide in the US
Code Information
Lot 5PB0183, exp 1/31/2027