FDA-Drug2026-07-08Class IICHEMICAL
Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for N-nitroso impurity
What this means
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain elevated levels of N-nitroso-cinacalcet, a manufacturing impurity that exceeds FDA safety limits. The affected bottles were distributed nationwide.
- Check if you take Cinacalcet 30 mg tablets made by Cipla — look at your bottle label.
- If your lot number matches 5PB0465, 5PB0466, 5PB0557, 5PB0629, 5PB0630, 5PB0633, 5PB0637, or 5PB0638, do not take it.
- Contact your pharmacist or doctor for a replacement or alternative medication.
- Do not flush or throw the medication in the trash; ask your pharmacist how to safely dispose of it.
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
31,824 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Cinacalcet Hydrochloride Tablets, 30 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 69097-410-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2026More Cipla recalls
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