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Food & drug recall · FDAMarch 16, 2026Serious

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Cipla USA, Inc.

The 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

Details

Units affected
63,192 bottles
Recall date
March 16, 2026
Brand
Cipla USA, Inc.
Model, lot or SKU numbers
Lot, expiry: 4PB0224, exp March-20264PB0505, 4PB0506, 4PB0507, exp September-20265PB0564, exp April-2027
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Cipla USA, Inc. — 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:”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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