Oxycodone Hydrochloride Oral Solution — Class III drug recall D-0231-2021
Terminated recall by Genus Lifesciences Inc., reported 2021-01-20, distributed nationwide. Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
| Recall number | D-0231-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genus Lifesciences Inc., Allentown, PA, United States |
| Recall initiated | 2020-12-23 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2021-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,171,550 cups |
| Reason classes | specification failure |
| NDC | 64950-0353, 64950-0353-01, 64950-0353-02, 64950-0353-03, 64950-0353-51, 64950-0353-52, 64950-0353-91, 64950-0353-92, 64950-0354, 64950-0354-05, 64950-0354-10, 64950-0354-45, 64950-0354-50, 64950-0354-55 |
| Lot numbers | 35400119A, 35400120A, 35400219A, 35400220A, 35400319A, 35400320A, 35400419A, 35400420B, 35400519A, 35400520A, 35400619A, 35400620A, 35400719A, 35400819A, 35400919A, 35401019A, 35401119A, 35401219A, 35401319A, 35401419A, 35401519A, 35401619A, 35401719A, 35401819A, 35401919A, 35402019A, 35402119A, 35402219A, 35402319A, 35402419A, 35402519A, 35402619A, 35402719A |
| Expiration dates | 2020-12-31, 2021-01-31, 2021-02-28, 2021-04-30, 2021-05-31, 2021-07-31, 2021-08-31, 2021-09-30, 2021-10-31, 2021-11-30, 2021-12-31, 2022-01-31 |
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 for recall
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
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-0231-2021. 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.