United StatesCinacalcet hydrochloride tablets 30 mg (NDC 69097-410-02), 60 mg (NDC 69097-411-02), and 90 mg (NDC 69097-412-02), 30 tablets per bottle, Rx only, manufactured for Cipla USA, lots 4PB0109 (exp 1/31/2026), 5PB0164, 5PB0172, and 5PB0183 (exp 1/31/2027), are being recalled nationwide in the United States. The recall was issued because CGMP deviations resulted in the presence of the nitrosamine impurity N-nitroso-cinacalcet above acceptable daily intake limits.
What's being recalled
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
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Recalling firm: Cipla USA, Inc., Warren, NJ, United States.
How to identify it
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027 Lot 5PB0164, exp 1/31/2027 Lot 5PB0183, exp 1/31/2027
The hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the US
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)