Oxycodone Hydrochloride Tablets — Class III drug recall D-0358-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2022-01-12, distributed in NY, OH. Out-of-specification impurity test result observed at 18-month long term stability time point.
| Recall number | D-0358-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2021-12-29 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2022-08-23 |
| Distributed | NY, OH |
| Quantity | 23,965 |
| Reason classes | specification failure |
| NDC | 43386-0430, 43386-0430-01, 43386-0430-03, 43386-0430-05, 43386-0431, 43386-0431-01, 43386-0431-03, 43386-0431-05, 43386-0432, 43386-0432-01, 43386-0432-03, 43386-0432-05, 43386-0433, 43386-0433-01, 43386-0433-03, 43386-0433-05, 43386-0434, 43386-0434-01, 43386-0434-03, 43386-0434-05 |
| Lot numbers | S000268 |
| Expiration dates | 2022-01-20 |
Product
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Reason for recall
Out-of-specification impurity test result observed at 18-month long term stability time point.
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-0358-2022. 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.