Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Impurity Risk
Accord Healthcare recalls Cinacalcet 90mg tablets (NDC 16729-442-10 and 16729-442-15) due to potential nitrosamine impurities exceeding safe levels. Consumers should contact the manufacturer for details.
Lower-risk recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Contact the company
What happened, in plain English
Accord Healthcare is recalling Cinacalcet tablets (90 mg, prescription only) because they contain a nitrosamine impurity that may exceed safe limits. This could pose a health risk with long-term use, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/32509-accord-healthcare-recalls-cinacalcet-tablets-due-to-nitrosamine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32509-accord-healthcare-recalls-cinacalcet-tablets-due-to-nitrosamine-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0032-2025
Cite this page
“Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32509-accord-healthcare-recalls-cinacalcet-tablets-due-to-nitrosamine-impurity-risk. Based on FDA recall #D-0032-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0032-2025%22&limit=1).
Why it’s dangerous
The tablets contain a nitrosamine impurity (N-nitroso-cinacalcet) that may exceed the acceptable daily intake limits. This impurity could potentially cause health issues with long-term use, though the recall does not specify immediate harm.
Who’s affected
Prescription users of Cinacalcet tablets (90 mg) who purchased the recalled bottles from pharmacies or online. Patients with kidney disease are most at risk due to the medication's use.
How to tell if you have this one
Check for the product name 'Cinacalcet Tablets, 90 mg, Rx Only' with NDC codes 16729-442-10 or 16729-442-15. The bottles may have lot numbers and expiry dates listed on the label.
- Brand
Accord Healthcare- 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
Terminated- Distribution
Nationwide in the USA and PR- NDC
16729-440-10, 16729-440-15, 16729-440-01, 16729-441-10, 16729-441-15, 16729-441-01, 16729-442-10, 16729-442-15, 16729-442-01
| Recall number | Product, codes & lots |
|---|---|
| D-0030-2025 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.; a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026 |
| D-0031-2025 | Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.; a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025 |
| D-0032-2025 | Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.; a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026 |
What to do — step by step
Contact Manufacturer
Reach out to Accord Healthcare for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0032-2025 (October 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0032-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.