Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIOngoing
Summary: Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02. Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
What is being recalled
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02
Why
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot #: 5PB0563, Exp 4/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0676-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 29, 2026 |
| Reported | July 8, 2026 |
| Company | Cipla USA, Inc. |
| Company location | Warren, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
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