Cipla cinacalcet 30 mg tablets recalled for impurity above limit
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain higher-than-acceptable levels of a chemical impurity called N-Nitroso Cinacalcet. The affected tablets were distributed nationwide. This is a manufacturing quality issue; no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Cipla recalls
What to do
- Check if your Cinacalcet bottle matches Lot 4PB0526, 4PB0527, 4PB0528, or 5PB0173
- Contact your pharmacist or doctor immediately if you have one of these lots
- Do not stop taking your medication without speaking to your doctor first
- Return the recalled tablets to your pharmacy
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 113,336 bottles
- Illnesses reported
- None reported
- Manufactured in
- 10 Independence Blvd, N/A, Warren, NJ, United States
- Classification
- Class II
- Recall number
- D-0449-2026
In the FDA's words
- Description
- 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 CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027 Distribution: Nationwide in the USA Affected quantity: 113,336 bottles
- Hazard
- CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
3 products in this recall
The agency lists each product separately. Check every one you might have.
- Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, I… (this page)D-0449-2026 · 113,336 bottles
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, I…D-0450-2026 · 96,096 bottles
- Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, I…D-0451-2026 · 63,192 bottles
More from Cipla
See all- Cipla USA fosfomycin granules recalled for failed impurity specs
ModerateFDAOct 14, 2026