CLASS III Drug recall · Reported 20 Jan 2021 · FDA Enforcement Report
Oxycodone Hydrochloride Oral Solution, USP 5 mg/ unit dose cups recalled
Genus Lifesciences is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/ unit dose cups, distributed nationwide in the US. The recall was initiated on 23 Dec 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0231-2021
- FDA event ID
- 87044
- Recalling firm
- Genus Lifesciences, Allentown, PA
- Manufacturer
- Genus Lifesciences Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Dec 2020
- FDA classified
- 15 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 23 Dec 2020 | Recall initiated by company | |
| 15 Jan 2021 | Classified by FDA | +23 days |
| 20 Jan 2021 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Product as listed by the FDA
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)
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Which lots are affected?
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.
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Oxycodone recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg recalledOxaydo | Zyla Life Sciences US | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |