Prednisolone Sodium Phosphate Oral Solution — Class III drug recall D-1340-2020
Terminated recall by Akorn, Inc., reported 2020-06-17, distributed nationwide. Discoloration: Out of Specification (OOS) result for APHA Color Test.
| Recall number | D-1340-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2020-06-05 |
| Classified | 2020-06-24 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 17,424 bottles |
| Reason classes | specification failure |
| NDC | 50383-0040-04 |
| Lot numbers | 365566, 365568 |
Product
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04
Reason for recall
Discoloration: Out of Specification (OOS) result for APHA Color Test.
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-1340-2020. 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.