Recalls / Class II
Class IID-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
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Active ingredient
- Cinacalcet Hydrochloride
- Route
- Oral
- NDCs
- 69097-410, 69097-411, 69097-412
- FDA application
- ANDA208915
- Affected lot / code info
- Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 63,504 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-11-14
- FDA classified
- 2025-12-09
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0224-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.