FDA Drug recall D-0358-2022
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class III recall of Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing out-of-specification impurity test result observed at 18-month long term stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0358-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-12-29 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | NY, OH |
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
Out-of-specification impurity test result observed at 18-month long term stability time point.
Identifiers
| ndc | 43386-432-01 |
|---|---|
| ndc | 43386-432-03 |
| ndc | 43386-432-05 |
| ndc | 43386-433-01 |
| ndc | 43386-433-03 |
| ndc | 43386-433-05 |
| ndc | 43386-430-01 |
| ndc | 43386-430-05 |
| ndc | 43386-430-03 |
| ndc | 43386-434-01 |
| ndc | 43386-434-05 |
| ndc | 43386-434-03 |
| ndc | 43386-431-01 |
| ndc | 43386-431-03 |
| ndc | 43386-431-05 |
| code_info | Lot # S000268, Exp. date January 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0358-2022%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.