Why it was recalled
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product description
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Lot numbers, UPCs & expiration codes
Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Where it was sold
Nationwide in the USA
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-0450-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 16, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 96,096 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0450-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98670
- Address
- 10 Independence Blvd
- Code information
- Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
- Postal code
- 07059-2730
- Report date
- Apr 22, 2026
- Product type
- Drugs
- Recall number
- D-0450-2026
- Classification
- Class II
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 96,096 bottles
- Reason for recall
- CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 16, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 10, 2026