Moderate riskFDA DrugApr 22, 2026Class II

Cipla USA cinacalcet tablets recalled for nitrosamine impurity

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 60 mg tablets because they contain higher-than-acceptable levels of N-Nitroso Cinacalcet, a nitrosamine impurity. This impurity can pose a health risk with long-term exposure. The affected lots were distributed nationwide.

From the FDA notice · Read the official notice ↗ · All Cipla recalls

What to do

Check if your Cinacalcet bottle matches one of these lot numbers: 4PB0215, 4PB0216, 4PB0515, 4PB0516, 4PB0517, or 5PB0167.
Do not take tablets from affected lots.
Contact your pharmacy or doctor immediately for a replacement or alternative medication.
Do not throw away your medication; ask your pharmacist how to safely dispose of it.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Cinacalcet Hydrochloride Tablets, 60 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: 69097-411-02
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 96,096 bottles
Illnesses reported: None reported
Manufactured in: 10 Independence Blvd, N/A, Warren, NJ, United States
Classification: Class II
Recall number: D-0450-2026

In the FDA's words

Description: Cinacalcet Hydrochloride Tablets, 60 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: 69097-411-02 CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027 Distribution: Nationwide in the USA Affected quantity: 96,096 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…
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… (this page)
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