Cipla USA recalls 60mg Cinacalcet tablets due to nitrosamine impurity exceeding safe limits. Patients should consult their doctor before using affected products.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA is recalling 60mg Cinacalcet hydrochloride tablets that contain a nitrosamine impurity above safe levels. This could pose health risks if taken as directed.
The tablets contain N-nitroso-cinacalcet, a nitrosamine impurity that exceeds the acceptable daily intake limits. This impurity could cause health issues if the medication is taken as intended.
Patients prescribed Cinacalcet hydrochloride tablets by a doctor are affected. Those using the recalled product without medical supervision may face health risks.
Check for the product name 'Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle' with NDC code 69097-411-02 and lot number 5PB0164.
Talk to your healthcare provider about whether you should stop using the recalled medication.
The recall states the product contains a nitrosamine impurity above safe limits, so it is not safe to take as directed.
Look for the NDC code 69097-411-02 and lot number 5PB0164 on the product label.
Contact your doctor to discuss whether you should stop using the product and follow their advice.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0225-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0225-2026 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.
