Class II · ModerateActive recall
Cinacalcet
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) 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
Where it was soldNationwide in the USA and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byIntas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA foreign manufacturer
| Brand name | CINACALCET |
| Generic name | CINACALCET |
| Active ingredient(s) | CINACALCET HYDROCHLORIDE |
| Distributed by / for | Accord Healthcare, Inc., Durham, NC 27703 |
| NDC | 16729-440-10 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | ACCORD HEALTHCARE, INC. |
| Distribution | Nationwide in the USA and PR |
| Quantity | N/A |
| Recall initiated | 2024-10-10 |
| Report date | 2024-11-06 |
| Recall completed | — |
| Recall number | D-0030-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Raleigh NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.