FDA-Drug2026-04-22Class IICHEMICAL
Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
HEAVY METALSNationwide distribution
Stop using Cipla cinacalcet 90 mg tablets
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.
Hazard
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
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 USA, Inc. recalls
- FDA-Drug2026-04-22Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for elevated N-Nitroso impurity
- FDA-Drug2026-04-22Cipla USA Cinacalcet Hydrochloride 60 mg tablets recalled for elevated nitrosamine impurity
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility assurance defect
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility concerns
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