Nystatin Cream — Class II drug recall D-1339-2020
Terminated recall by Crown Laboratories, reported 2020-07-01, distributed nationwide. Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
| Recall number | D-1339-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Crown Laboratories, Johnson City, TN, United States |
| Recall initiated | 2020-06-10 |
| Classified | 2020-06-24 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2021-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 35,931 tubes |
| Reason classes | potency, specification failure |
| NDC | 00316-0221, 00316-0221-15, 00316-0221-30 |
| Lot numbers | Y0378 |
| Expiration dates | 2021-07 |
Product
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
Reason for recall
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1339-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.