FDA Drug recall D-0368-2022
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., A…
- FDA Drug
- Class III
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class III recall of Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., A… by Akorn, citing labeling: Missing Label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0368-2022 |
| 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
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Reason
Labeling: Missing Label
Identifiers
| code_info | Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023 |
|---|
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-0368-2022%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.