Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Reported: December 17, 2025 Initiated: November 14, 2025 #D-0224-2026
Product Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Details
- Recalling Firm
- Cipla USA, Inc.
- Units Affected
- 63,504 bottles
- Distribution
- Nationwide in the US
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02. Recalled by Cipla USA, Inc.. Units affected: 63,504 bottles.
Why was this product recalled? ▼
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2025. Severity: Moderate. Recall number: D-0224-2026.
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