Oxycodone Hydrochloride Oral Solution — Class III drug recall D-0368-2022
Terminated recall by Akorn, Inc., reported 2022-01-19, distributed nationwide. Labeling: Missing Label
| Recall number | D-0368-2022 |
|---|---|
| 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 | 8,184 bottles |
| Reason classes | labeling |
| NDC | 50383-0961-34 |
| Lot numbers | 377186, 377188 |
| Expiration dates | 2023-02-28, 2023-03-31 |
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 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-0368-2022. 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.