Cinacalcet Hydrochloride Tablets 30 mg
Cipla recalls Cinacalcet HCl 30 mg tablets due to nitrosamine impurity above ADI.
Stop using the recalled tablets and contact your healthcare provider for guidance. Return the product to the place of purchase for a refund or contact Cipla USA for further instructions.
Recall at a glance
- Quantity recalled
- 31,824 bottles
Why it was recalled
Cipla USA is recalling Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottles, due to the presence of N-nitroso-cinacalcet, a nitrosamine impurity above the acceptable daily intake, resulting from cGMP deviations.
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
| Lot code | Strength | NDC / UPC | Recall # |
|---|---|---|---|
| 5PB0465, 5PB0466, 5PB0557, 2027 | 30 mg | NDC 69097-410-02 | D-0661-2026 |
| 5PB0165, 5PB0166, 2027 | 60 mg | NDC 69097-411-02 | D-0675-2026 |
| 5PB0563, 2027 | 90 mg | NDC 69097-412-02 | D-0676-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Impurity or Degradation recalls
Other recent recalls from Cipla USA, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification