FDA-Drug2026-04-22Class IICHEMICAL
Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for elevated N-Nitroso impurity
HEAVY METALSNationwide distribution
Stop using Cipla Cinacalcet Hydrochloride tablets
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain higher-than-acceptable levels of a chemical impurity called N-Nitroso Cinacalcet. The affected tablets were distributed nationwide. This is a manufacturing quality issue; no injuries have been reported.
- Check if your Cinacalcet bottle matches Lot 4PB0526, 4PB0527, 4PB0528, or 5PB0173
- Contact your pharmacist or doctor immediately if you have one of these lots
- Do not stop taking your medication without speaking to your doctor first
- Return the recalled tablets to your pharmacy
Hazard
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Sold states
Nationwide in the USA
Affected count
113,336 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Cinacalcet Hydrochloride Tablets, 30 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: 69097-410-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0449-2026More Cipla USA, Inc. recalls
- FDA-Drug2026-04-22Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
- 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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