Cipla USA recalls 60mg Cinacalcet tablets due to N-Nitroso contamination exceeding safe limits. Affected lots manufactured in India with specific expiry dates. Consumers should contact Cipla for details.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA is recalling 60mg Cinacalcet hydrochloride tablets that may contain N-Nitroso compounds above safe levels. This could pose health risks with long-term use, especially for patients with kidney disease who take these medications.
The tablets may contain N-Nitroso compounds in amounts exceeding the acceptable daily intake limit. This chemical has been linked to potential health risks, particularly with long-term use. However, the exact risk level for individual patients is not clearly specified in the recall notice.
People with kidney disease who require Cinacalcet for treatment are most at risk. The recall affects specific batches manufactured in India with particular lot numbers and expiry dates.
Check for the NDC code 69097-411-02 on the bottle. The affected lots include 4PB0215, 4PB0216 (expiring March 2026), 4PB0515, 4PB0516 (expiring September 2026), and 4PB0517 (expiring September 2026), as well as 5PB0167 (expiring January 2027).
Look for the NDC code 69097-411-02 on the bottle label to identify affected lots.
The recall is due to CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit.
Contact Cipla USA directly for specific instructions on how to handle the product.
Yes, affected lots include 4PB0215, 4PB0216 (expiring March 2026), 4PB0515, 4PB0516 (expiring September 2026), 4PB0517 (expiring September 2026), and 5PB0167 (expiring January 2027).
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0450-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0450-2026 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.
