Nystatin — Class II drug recall D-0652-2016
Terminated recall by Perrigo Company PLC, reported 2016-02-10, distributed nationwide. Labeling: label error on declared strength.
| Recall number | D-0652-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Company PLC, Allegan, MI, United States |
| Recall initiated | 2016-01-18 |
| Classified | 2016-02-04 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 918 units |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00305740404157 |
| NDC | 00574-0404-15 |
| Lot numbers | 2015080484 |
| Expiration dates | 2016-02 |
Product
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Reason for recall
Labeling: label error on declared strength.
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-0652-2016. 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.