Moderate riskFDA DrugApr 22, 2026Class II

Cipla cinacalcet tablets recalled for N-nitroso cinacalcet

Cipla USA is recalling certain batches of cinacalcet 90 mg tablets because they contain higher-than-safe levels of a chemical impurity called N-Nitroso Cinacalcet. The affected bottles were distributed nationwide. No injuries have been reported.

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

What to do

Check if your cinacalcet matches one of the recalled lot numbers: 4PB0224 (expires March 2026), 4PB0505, 4PB0506, 4PB0507 (expire September 2026), or 5PB0564 (expires April 2027).
Contact your pharmacy or doctor if you have one of these lots.
Do not stop taking your medication without talking to your doctor—they can provide a safe alternative.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 63,192 bottles
Illnesses reported: None reported
Manufactured in: 10 Independence Blvd, N/A, Warren, NJ, United States
Classification: Class II
Recall number: D-0451-2026

In the FDA's words

Description: Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02 CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027 Distribution: Nationwide in the USA Affected quantity: 63,192 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…
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… (this page)
D-0451-2026 · 63,192 bottles