FDA-Drug2026-07-08Class IICHEMICAL
Cipla Cinacalcet Hydrochloride 90 mg tablets recalled for N-nitroso impurity above acceptable limits
What this means
Cipla USA is recalling Cinacalcet Hydrochloride 90 mg tablets (lot 5PB0563, expiring 4/30/2027) because they contain elevated levels of N-nitroso-cinacalcet, a potentially harmful impurity that exceeds acceptable daily intake limits. This is a manufacturing quality issue.
- Check if you take Cinacalcet 90 mg tablets and verify the lot number on your bottle.
- Contact your pharmacy or doctor if you have lot 5PB0563.
- Do not stop taking your medication without speaking to your doctor first; they can provide an alternative or replacement.
- Return affected medication to your pharmacy for proper disposal.
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, 90 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 69097-412-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0676-2026More Cipla recalls
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