Cinacalcet Hydrochloride Tablets 30 mg
Cipla recalls Cinacalcet HCl 30 mg tablets over N-Nitroso impurity above acceptable limit.
Stop using the recalled tablets and contact your healthcare provider for guidance. Return the product to the place of purchase or dispose of it according to local regulations.
Why it was recalled
Cipla USA is recalling Cinacalcet Hydrochloride Tablets, 30 mg, due to CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit, which may increase the risk of cancer.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Cinacalcet Hydrochloride Tablets
| Strength | NDC / UPC | Recall # |
|---|---|---|
| 90 mg | NDC 69097-412-02 | D-0451-2026 |
| 30 mg | NDC 69097-410-02 | D-0449-2026 |
| 60 mg | NDC 69097-411-02 | D-0450-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Cipla USA, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification