FDA Drug recall D-0231-2021
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc
- FDA Drug
- Class III
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class III recall of Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc by Genus Lifesciences, citing presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0231-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-12-23 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Genus Lifesciences |
| Distribution | US |
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)
Reason
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Identifiers
| ndc | 64950-353-03 |
|---|---|
| ndc | 64950-353-01 |
| ndc | 64950-353-91 |
| ndc | 64950-353-51 |
| ndc | 64950-353-02 |
| ndc | 64950-353-92 |
| ndc | 64950-353-52 |
| ndc | 64950-354-10 |
| ndc | 64950-354-50 |
| ndc | 64950-354-05 |
| ndc | 64950-354-55 |
| ndc | 64950-354-45 |
| code_info | Lot # 35400119A, 35400219A, 35400319A, 35400419A , 35400519A , 35400619A, EXP 12/31/20; 35400719A, 35400819A, EXP 1/31/…Lot # 35400119A, 35400219A, 35400319A, 35400419A , 35400519A , 35400619A, EXP 12/31/20; 35400719A, 35400819A, EXP 1/31/21; 35400919A, 35401019A, 35401119A, EXP 2/28/21; 35401219A, 35401319A, EXP 4/30/21; 35401419A, 35401519A, 35401619A, EXP 5/31/21; 35401719A, 35401819A, EXP 7/31/21; 35401919A, 35402019A, EXP 8/31/21; 35402119A, 35402219A, 35402319A, 35402419A, EXP 9/30/21; 35402519A, EXP 10/31/21; 35402619A, 35402719A, EXP 11/30/21; 35400120A, 35400220A, 35400320A, 35400420B, EXP 12/31/21; 35400520A, EXP 1/31/22, 35400620A, EXP 1/31/22. |
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-0231-2021%22
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