Class II · ModerateActive recall
Cinacalcet
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Where it was soldNationwide in the USA
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 N-Nitroso Cinacalcet above the acceptable daily intake 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 byCipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059 foreign manufacturer
| Brand name | CINACALCET |
| Generic name | CINACALCET |
| Active ingredient(s) | CINACALCET HYDROCHLORIDE |
| Distributed by / for | Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059 |
| NDC | 69097-411-02 |
Show the full FDA record
| Full product label | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 |
| Recalling firm | Cipla USA, Inc. |
| Distribution | Nationwide in the USA |
| Quantity | 96,096 bottles |
| Recall initiated | 2026-03-16 |
| Report date | 2026-04-22 |
| Recall completed | — |
| Recall number | D-0450-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Warren 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.