Nystatin Oral Suspension — Class III drug recall D-1080-2019
Terminated recall by Akorn, Inc., reported 2019-04-10, distributed in AR, MS. Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during
| Recall number | D-1080-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2019-03-28 |
| Classified | 2019-04-04 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2020-04-22 |
| Distributed | AR, MS |
| Quantity | 2,796 bottles |
| Reason classes | specification failure |
| NDC | 50383-0587-16 |
| Lot numbers | 3/19, 356527 |
Product
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
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-1080-2019. 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.