Cipla USA recalls 30mg Cinacalcet tablets due to N-Nitroso contamination exceeding safe limits. Affected lots manufactured in India for US distribution. Consumers should contact Cipla for details.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipl: USA recalls 30mg Cinacalcet tablets made by Cipla Ltd. in India for US distribution. The tablets contain N-Nitroso Cinacalcet above safe levels, which could pose health risks with long-term use.
The tablets contain N-Nitroso Cinacalcet levels above the acceptable daily intake limit. This chemical is a potential carcinogen that could cause health issues with prolonged use.
Prescription users of Cinacalcet Hydrochloride Tablets, 30 mg, 30 tablets per bottle. Patients with kidney disease who require this medication are most at risk.
Check for NDC code 69097-410-02 on the bottle. Affected lots include 4PB0526-4PB0528 (expiring September 2026) and 5PB0173 (expiring January 2027).
Look for NDC code 69097-410-02 on the bottle label.
Reach out to Cipla USA for specific instructions on handling affected lots.
The recall indicates N-Nitroso levels exceed safe limits, so they should not be used without consulting a healthcare provider.
Check for NDC code 69097-410-02 on the bottle. Affected lots include 4PB0526-4PB0528 (expiring September 2026) and 5PB0173 (expiring January 2027).
Contact Cipla USA for specific instructions on handling affected lots.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0449-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0449-2026 from Cipla. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
