Cipla USA recalls 30mg Cinacalcet tablets due to nitrosamine impurity exceeding safe limits. Patients with high calcium levels should stop using these specific lots.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA is recalling 30mg Cinacalcet hydrochloride tablets that contain a nitrosamine impurity above safe levels. This could cause health risks for people with high calcium levels who take these medications.
The tablets contain N-nitroso-cinacalcet, a nitrosamine impurity that exceeds the safe daily intake limit. This impurity could cause health issues for people with high calcium levels, especially those with kidney problems.
People prescribed Cinacalcet for high calcium levels who use the specific lots mentioned in the recall. Those with kidney issues or on dialysis are most at risk.
Check for the NDC code 69097-410-02 and lot numbers 4PB0109 (expires 1/31/2026) or 5PB0172 (expires 1/31/2027). These tablets are prescription-only and sold by Cipla USA.
Look for the NDC code 69097-410-02 and lot numbers 4PB0109 or 5PB0172 on the bottle.
The recall states the tablets contain a nitrosamine impurity above safe limits, so they are not safe for use.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
The recall only affects the specific lots mentioned with NDC 69097-410-02.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0224-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0224-2026 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.
