Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 16729-0441-10 recalled?

Cinacalcet · 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-10)

Yes — this exact package was recalled

1 FDA recall names the code 16729-0441-10 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Cinacalcet
Strength
CINACALCET HYDROCHLORIDE 60 mg/1
Form
Tablet, Film Coated · Oral
Labeler
Accord Healthcare, Inc.
Type
Human Prescription Drug
Product code
16729-0441

Recalls naming this package

Class II ยท Moderate risk

Cinacalcet Tablets

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Terminated Nitrosamine impurity Accord Healthcare, INC. D-0031-2025

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler