Cinacalcet Hydrochloride Tablets, 30 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 69097-410-02

FDA recall notice · announced July 8, 2026 · Cipla

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
Quantity: 31,824 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0676-2026)
- Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren (D-0675-2026)
- Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren (D-0661-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.