Morphine Sulfate Oral Solution 100 mg per 5 mL — Class III drug recall D-0367-2022
Terminated recall by Akorn, Inc., reported 2022-01-19, distributed nationwide. Labeling: Missing Label
| Recall number | D-0367-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2021-12-03 |
| Classified | 2022-01-13 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2022-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 10,836 bottles |
| Reason classes | labeling |
| NDC | 50383-0965-30 |
| Lot numbers | 375153 |
| Expiration dates | 2022-10-31 |
Product
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
Reason for recall
Labeling: Missing Label
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-0367-2022. 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.