FDA Drug recall D-1339-2020
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc by Crown Laboratories, citing subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1339-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-10 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Crown Laboratories |
| Distribution | US |
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
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Identifiers
| ndc | 0316-0221-15 |
|---|---|
| ndc | 0316-0221-30 |
| code_info | Lot: Y0378, EXP 07/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1339-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.