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DRUG RECALLMODERATE
Cinacalcet Hydrochloride Tablets 30 mg
Cipla recalls Cinacalcet HCl 30 mg tablets over N-nitroso impurity above safe limit.
What to do
Check your prescription bottle for NDC 69097-410-02. Stop using the affected tablets and return them to the pharmacy or contact Cipla USA for a refund or replacement.
Why it was recalled
Cipla USA is recalling Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottles due to cGMP deviations resulting in the presence of N-nitroso-cinacalcet above the acceptable daily intake.
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, 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 | D-0661-2026 |
| 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, NJ 07059, NDC 69097-411-02 | D-0675-2026 |
| 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 | D-0676-2026 |
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