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

Is NDC 16729-0371-16 recalled?

Tadalafil · 500 TABLET, FILM COATED in 1 BOTTLE (16729-371-16)

Yes — this exact package was recalled

1 FDA recall names the code 16729-0371-16 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
Tadalafil
Strength
TADALAFIL 10 mg/1
Form
Tablet, Film Coated · Oral
Labeler
Accord Healthcare Inc.
Type
Human Prescription Drug
Product code
16729-0371

Recalls naming this package

Class II ยท Moderate risk

Tadalafil Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-371-10 D-0416-2023

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