Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
From the FDA notice · Read the official notice ↗ · All Cipla recalls
What to do
The agency's notice has the remedy and who to contact.
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 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
- 63,504 bottles
- Illnesses reported
- None reported
- Manufactured in
- 10 Independence Blvd, N/A, Warren, NJ, United States
- Classification
- Class II
- Recall number
- D-0224-2026
In the FDA's words
- Description
- Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027 Distribution: Nationwide in the US Affected quantity: 63,504 bottles
- Hazard
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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 for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ… (this page)D-0224-2026 · 63,504 bottles
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ…D-0225-2026 · 15,744 bottles
- Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ…D-0226-2026 · 12,576 bottles
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ModerateFDAOct 14, 2026