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

Is NDC 0316-0221-30 recalled?

Nystatin Cream · 1 TUBE in 1 CARTON (0316-0221-30) / 30 g in 1 TUBE

Yes — this exact package was recalled

1 FDA recall names the code 0316-0221-30 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
Nystatin Cream
Strength
NYSTATIN 100000 [USP'U]/g
Form
Cream · Topical
Labeler
Crown Laboratories
Type
Human Prescription Drug
Product code
0316-0221

Recalls naming this package

Class II · Moderate risk

Nystatin Cream

Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

Terminated Wrong potency / content Crown Laboratories NDC 0316-0221-15 D-1339-2020
Class II · Moderate risk

Nystatin Cream

Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

Terminated Wrong potency / content Crown Laboratories NDC 0316-0221-30 D-1338-2020

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.