Aurobindo Cinacalcet 60mg Tablets Recall: N-Nitroso Impurity Risk
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.
Recall notice
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/32454-aurobindo-cinacalcet-60mg-tablets-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32454-aurobindo-cinacalcet-60mg-tablets-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0078-2025
Cite this page
“Aurobindo Cinacalcet 60mg Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32454-aurobindo-cinacalcet-60mg-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0078-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0078-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Aurobindo Pharma- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0077-2025 | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.; Lot #: a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, Exp 12/31/2024 | 102576 bottles |
| D-0078-2025 | Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.; Lot #: a) CFSB23001A, Exp 03/31/2025, CFSB23002A, Exp 07/31/2025; CFSB23003A, Exp 10/31/2025; CFSB23004A, Exp 10/31/2025; b) P2300196, 12/31/2024 | 3336 bottles |
| D-0079-2025 | Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05; Lot #: a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024 | — |
What to do — step by step
Contact Pharmacy
Reach out to your pharmacy to confirm if you have the recalled tablets and get instructions on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0078-2025 (November 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0078-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.