Cipla USA recalls 90mg Cinacalcet tablets due to N-Nitroso contamination exceeding safe limits. Rx-only medication with specific lot numbers and expiration dates. Consumers should contact Cipla for details.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA is recalling 90mg Cinacalcet hydrochloride tablets that may contain N-Nitroso compounds above safe levels. This could pose a health risk with long-term use, so affected patients should stop using the medication and contact Cipla for guidance.
The tablets contain N-Nitroso compounds in amounts exceeding the acceptable daily intake limit. This chemical is linked to potential health risks, particularly with long-term use. The hazard is not immediate but could accumulate over time.
Patients prescribed Cinacalcet hydrochloride tablets for calcium regulation who received the recalled lots. Those with kidney disease or on dialysis are at higher risk due to medication sensitivity.
Check for the NDC code 69097-412-02 on the bottle. The lot numbers include 4PB0224 (expires March 2026), 4PB0505-07 (expires September 2026), and 5PB0564 (expires April 2027).
Look for the NDC code 69097-412-02 and specific lot numbers on the bottle.
Reach out to Cipla USA at 1-800-834-8426 or via their website for assistance with the recall.
The recall indicates the tablets may contain N-Nitroso compounds above safe limits. Patients should not use the recalled lots and contact Cipla for guidance.
Stop using the recalled tablets and contact Cipla USA for instructions on returning them or getting a replacement.
Check the NDC code 69097-412-02 and lot numbers 4PB0224, 4PB0505-07, or 5PB0564 on the bottle.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0451-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0451-2026 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.
