FDA-Drug2026-07-08Class IICHEMICAL
Cipla Cinacalcet Hydrochloride 60 mg tablets recalled for N-nitroso impurity above safe limits
What this means
Cipla USA is recalling certain batches of Cinacalcet Hydrochloride 60 mg tablets because they contain N-nitroso-cinacalcet, a chemical impurity, at levels above the FDA's acceptable daily intake. The affected lots were distributed nationwide. No injuries have been reported.
- Check if you take Cinacalcet 60 mg tablets; verify the lot number and expiration date on your bottle.
- If you have one of the affected lots (5PB0165, 5PB0166, 5PB0552, 5PB0642, 5PB0643, or 5PB0644), contact your pharmacist or doctor before stopping your medication.
- Do not stop taking your medication without medical guidance; your doctor can advise whether to switch to another supply.
The agency's original wording
Hazard
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
N/A
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count 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-0675-2026More Cipla recalls
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