FDA-Drug2026-04-22Class IICHEMICAL
Cipla USA Cinacalcet Hydrochloride 60 mg tablets recalled for elevated nitrosamine impurity
What this means
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 60 mg tablets because they contain higher-than-acceptable levels of N-Nitroso Cinacalcet, a nitrosamine impurity. This impurity can pose a health risk with long-term exposure. The affected lots were distributed nationwide.
- Check if your Cinacalcet bottle matches one of these lot numbers: 4PB0215, 4PB0216, 4PB0515, 4PB0516, 4PB0517, or 5PB0167.
- Do not take tablets from affected lots.
- Contact your pharmacy or doctor immediately for a replacement or alternative medication.
- Do not throw away your medication; ask your pharmacist how to safely dispose of it.
The agency's original wording
Hazard
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
96,096 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0450-2026More Cipla recalls
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 60 mg tablets recalled for N-nitroso impurity above safe limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 90 mg tablets recalled for N-nitroso impurity above acceptable limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for N-nitroso impurity
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