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

Is NDC 45802-0059-35 recalled?

Nystatin · 1 TUBE in 1 CARTON (45802-059-35) / 15 g in 1 TUBE

Yes — this exact package was recalled

1 FDA recall names the code 45802-0059-35 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.

1 of these recalls is still ongoing.

Active ingredient
Nystatin
Strength
NYSTATIN 100000 [USP'U]/g
Form
Cream · Topical
Labeler
Padagis Israel Pharmaceuticals Ltd
Type
Human Prescription Drug
Product code
45802-0059

Recalls naming this package

Class II ยท Moderate risk

Nystatin Cream USP

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Ongoing Wrong potency / content Padagis US LLC NDC 45802-059-35 D-0677-2026

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