Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx
See all recalls from Cipla USA, Inc. →Recalled Product
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, NJ 07059, NDC 69097-411-02
Hazard / Issue
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Cinacalcet Hydrochloride Tablets, 60 →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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