PrednisoLONE Oral Solution USP — Class II drug recall D-1361-2022
Ongoing recall by Akorn, Inc, reported 2022-08-24, distributed nationwide. Defective Container: Product has incomplete induction seals.
| Recall number | D-1361-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc, Gurnee, IL, United States |
| Recall initiated | 2022-08-01 |
| Classified | 2022-08-19 |
| Reported by FDA | 2022-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 14,712 bottles |
| Reason classes | packaging |
| NDC | 50383-0042-24 |
| Lot numbers | 379804 |
| Expiration dates | 2023-08-31 |
Product
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Reason for recall
Defective Container: Product has incomplete induction seals.
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-1361-2022. 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.