The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1338-2020·Announced 2020-07-01

Crown Laboratories Recalls Subpotent Nystatin Cream Tubes

Crown Laboratories is recalling 62,274 tubes of Nystatin Cream because the product failed potency testing at the 9-month interval.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety risk like toxicity or contamination.

Plain-English summary

Crown Laboratories, Inc. is recalling 62,274 tubes of Nystatin Cream, USP 100,000 units per gram, 30 grams. The product is a prescription-only topical antifungal cream manufactured and distributed by Crown Laboratories in Johnson City, Tennessee. The specific lot affected is Y0378A, with an expiration date of 07/2021, and the National Drug Code (NDC) is 0316-0221-30.

The recall was initiated because the product was found to be subpotent, meaning it was out of specification for assay at the 9-month interval. This indicates that the active ingredient, nystatin, may not be present at the required strength to ensure the drug's effectiveness.

The affected product was distributed nationwide in the United States. Consumers and healthcare providers who have this specific lot of Nystatin Cream should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
NYSTATIN CREAM (NYSTATIN CREAM)
Brand
NYSTATIN CREAM
Manufacturer
Crown Laboratories
Category
Drug — Topical Antifungal
Hazard
Affected units
62,274

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: Y0378A
  • EXP 07/2021

UPCs (1)

  • 0303160221156

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Crown Laboratories under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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