Dr. Reddy's recalls 30mg Cinacalcet tablets with N-nitroso impurity above FDA limits. Affected lots manufactured in India, expiring through 2026. No remedy stated in official notice.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Dr. Reddy's recalls certain 30mg Cinacalcet tablets due to a chemical impurity that may pose health risks. This recall affects specific production lots with expiration dates through 2026. Patients should consult their doctor about alternative treatments.
The tablets contain N-nitroso impurities above FDA-recommended levels. These impurities can potentially cause health issues, though the exact risk level isn't specified in the recall notice. The impurity is a result of manufacturing deviations that occurred during production.
Patients prescribed Cinacalcet tablets for hyperparathyroidism who have the specific lots listed in the recall. Those with kidney issues or on dialysis are at higher risk due to the medication's use.
Check for the product name 'Cinacalcet Tablets, 30 mg, 30-count bottle' with the specific lot numbers listed in the recall. The expiration dates range from November 2024 through February 2026.
Identify the lot number and expiration date on the tablet packaging to determine if it's affected.
The recall is due to CGMP deviations where N-nitroso Cinacalcet impurities were found above FDA recommended limits.
The official notice does not specify any remedy or action steps for affected patients.
Check the lot number and expiration date on the packaging against the list of affected lots provided in the recall notice.
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-0026-2025 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0026-2025 from Dr. Reddy's. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
