Class II · ModerateActive recall
Cinacalcet
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.
Where it was soldUSA Nationwide.
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: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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 byMade in India foreign manufacturer
| Brand name | CINACALCET |
| Generic name | CINACALCET |
| Active ingredient(s) | CINACALCET HYDROCHLORIDE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 43598-368-30 |
Show the full FDA record
| Full product label | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | USA Nationwide. |
| Quantity | 35880 bottles |
| Recall initiated | 2024-10-09 |
| Report date | 2024-11-06 |
| Recall completed | — |
| Recall number | D-0027-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Princeton NJ 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.