Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0224-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 14, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- 63,504 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0224-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97974
- Address
- 10 Independence Blvd
- Code information
- Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
- Postal code
- 07059-2730
- Report date
- Dec 17, 2025
- Product type
- Drugs
- Recall number
- D-0224-2026
- Classification
- Class II
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 63,504 bottles
- Reason for recall
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Nov 14, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 9, 2025