Cipla USA recalls 90mg Cinacalcet tablets due to nitrosamine impurity exceeding safe limits. Patients should consult their doctor for alternatives.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA is recalling 90mg Cinacalcet hydrochloride tablets that contain a nitrosamine impurity above safe levels. This could pose health risks to patients using these prescription medications.
The tablets contain N-nitroso-cinacalcet, a nitrosamine impurity that exceeds the acceptable daily intake limits. This impurity could potentially cause health issues when taken regularly.
Patients prescribed Cinacalcet hydrochloride tablets for kidney disease who use the recalled product. Those with kidney disease are most at risk.
Check for the product name 'Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle' with NDC 69097-412-02 and lot number 5PB0183, expiring 1/31/2027.
Talk to your healthcare provider about alternative treatments for your kidney condition.
The recall indicates the product contains a nitrosamine impurity above safe limits, so it is not safe to use.
The recall does not specify a remedy, so contact your doctor for guidance.
Look for the product name 'Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle' with NDC 69097-412-02 and lot number 5PB0183, expiring 1/31/2027.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0226-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0226-2026 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.
