Aurobindo Pharma recalls 60mg Cinacalcet tablets with N-nitroso impurity above FDA limits. Rx-only medication affected by specific lot numbers and packaging. Consumers should contact pharmacy for details.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Aurobindo Pharma is recalling 60mg Cinacalcet tablets due to a chemical impurity that may exceed FDA safety limits. This recall affects specific lot numbers and packaging types sold through pharmacies. The impurity could pose a health risk if the medication is taken as directed.
The tablets contain an impurity called N-nitroso Cinacalcet that exceeds the FDA's interim safety limit. This impurity could potentially cause health issues if the medication is taken as prescribed, especially for patients with kidney conditions who rely on it.
People who have the specific 60mg Cinacalcet tablets with the listed lot numbers and packaging (30-count or 500-count HDPE bottles) from pharmacies. Those with chronic kidney disease or on dialysis are most at risk due to the medication's use.
Check your 60mg Cinacalcet tablets for the specific lot numbers: CFSB23001A to CFSB23004A (expiring 03/31/2025 to 10/31/2025) or P2300196 (expiring 12/31/2024). The tablets come in either 30-count or 500-count HDPE bottles.
Reach out to your pharmacy to confirm if you have the recalled tablets and get instructions on what to do next.
The recall is due to a chemical impurity that may exceed FDA safety limits. Do not take the recalled tablets until you get advice from your pharmacy.
Lot numbers CFSB23001A to CFSB23004A (expiring 03/31/2025 to 10/31/2025) and P2300196 (expiring 12/31/2024).
Check the lot number on the bottle and compare it to the listed numbers: CFSB23001A to CFSB23004A or P2300196.
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0078-2025 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-0078-2025 from Aurobindo Pharma. 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.
