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DRUG RECALLMODERATE
Cinacalcet Hydrochloride Tablets
Cipla recalls Cinacalcet HCl tablets over CGMP deviations and nitrosamine impurity.
What to do
Check your bottle for NDC 69097-410-02 (30 mg) or 69097-411-02 (60 mg). Stop using the tablets and contact Cipla USA for return and refund instructions.
Why it was recalled
Cipla USA is recalling Cinacalcet Hydrochloride Tablets 30 mg and 60 mg due to CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Recall # |
|---|---|
| Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02 | D-0451-2026 |
| Cinacalcet Hydrochloride Tablets, 30 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: 69097-410-02 | D-0449-2026 |
| 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 | D-0450-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Cipla USA, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification