NYSTATIN 150 MU — Class II drug recall D-0157-2024
Ongoing recall by Fagron, Inc, reported 2023-12-27. Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
| Recall number | D-0157-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron, Inc, Saint Paul, MN, United States |
| Recall initiated | 2023-12-11 |
| Classified | 2023-12-21 |
| Reported by FDA | 2023-12-27 |
| Countries outside the US | CA |
| Quantity | 52 containers |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00351552004115 |
| NDC | 51552-0041-01 |
| Lot numbers | 221031-U42104 |
| Expiration dates | 2025-04-30 |
Product
NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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-0157-2024. 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.