FDA Drug recall D-0367-2022
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…
- FDA Drug
- Class III
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class III recall of 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… by Akorn, citing labeling: Missing Label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0367-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-12-03 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Labeling: Missing Label
Identifiers
| code_info | Lot: 375153 Exp. 10/31/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0367-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.