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

Is NDC 47335-0539-81 recalled?

Niacin · 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-81)

Yes — this exact package was recalled

1 FDA recall names the code 47335-0539-81 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
Niacin
Strength
NIACIN 500 mg/1
Form
Tablet, Film Coated, Extended Release · Oral
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
47335-0539

Recalls naming this package

Class II ยท Moderate risk

Niacin Extended-Release Tablets

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Completed Microbial contamination Sun Pharmaceutical Industries INC NDC 47335-539-81 D-0270-2024

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