Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets
- Recalling company
- Cipla USA, Inc.
- 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
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 14, 2025
- Reported
- Dec 17, 2025
- Distribution
- Nationwide in the US
- Status
- Ongoing
- Quantity
- 63,504 bottles
- Lot / codes
- Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
- Company location
- Warren, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0224-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0224-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.