Crown Laboratories Recalls Nystatin Cream for Subpotent Drug Levels
Crown Laboratories is recalling Nystatin Cream, USP, because the product failed potency testing at the 9-month interval.
What this means for you
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 typically involves 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 physical injury risk like choking or fire, fitting the Moderate category for low-risk contamination or labeling/potency errors without reported serious injury.
Plain-English summary
Crown Laboratories is recalling Nystatin Cream, USP, 100,000 units per gram, 15 grams, Rx Only. The recall affects 35,931 tubes of the product, identified by Lot Y0378 with an expiration date of 07/2021. The product was distributed nationwide in the USA.
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 medication may not contain the full amount of the active ingredient required to be effective.
Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or contact their healthcare provider for a replacement. The product is a prescription-only medication manufactured and distributed by Crown Laboratories, Inc.
The recalled product
- Product
- NYSTATIN CREAM (NYSTATIN CREAM)
- Brand
- NYSTATIN CREAM
- Manufacturer
- Crown Laboratories
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 35,931
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: Y0378
- 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 →Related recalls
Same brand · NYSTATIN CREAM
- ModerateCrown Laboratories Recalls Subpotent Nystatin Cream Tubes
FDA (Drugs) · 2020-07-01
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