FDA-Drug2026-04-22Class IICHEMICAL
Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
What this means
Cipla USA is recalling certain batches of cinacalcet 90 mg tablets because they contain higher-than-safe levels of a chemical impurity called N-Nitroso Cinacalcet. The affected bottles were distributed nationwide. No injuries have been reported.
- Check if your cinacalcet matches one of the recalled lot numbers: 4PB0224 (expires March 2026), 4PB0505, 4PB0506, 4PB0507 (expire September 2026), or 5PB0564 (expires April 2027).
- Contact your pharmacy or doctor if you have one of these lots.
- Do not stop taking your medication without talking to your doctor—they can provide a safe alternative.
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
63,192 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2026More 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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