Drug recall D-0224-2026
Product
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.
Lots and codes
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Recall details
- Recalling firm
- Cipla USA, Inc., Warren, NJ
- Quantity
- 63,504 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 14, 2025
Related products
- Cinacalcet – drug information
- NDC 69097-410 Cinacalcet · Cinacalcet Hydrochloride 30 mg/1 · Cipla USA Inc.
- NDC 69097-412 Cinacalcet · Cinacalcet Hydrochloride 90 mg/1 · Cipla USA Inc.
- NDC 69097-411 Cinacalcet · Cinacalcet Hydrochloride 60 mg/1 · Cipla USA Inc.