Genus Lifesciences Inc. recalls Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05
Genus Lifesciences recalls 5 mg/5mL oxycodone oral solution units with particulate matter. Affected lots have specific NDC and expiration dates. Stop using if you have these products.
Stop using this now
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Contact the company & request your remedy
What happened, in plain English
Genus Lifesciences is recalling oxycodone oral solution units that contain foreign particles. This could cause serious injury if the particles enter the bloodstream during use. The recall affects specific lots with known expiration dates and NDC numbers. Read more at govinfonow.com/recall/36566-genus-lifesciences-oxycodone-oral-solution-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/36566-genus-lifesciences-oxycodone-oral-solution-recall-particulate-matter-hazard · Updated October 4, 2026 · FDA enforcement record: FDA #D-0231-2021
Cite this page
“Genus Lifesciences Oxycodone Oral Solution Recall: Particulate Matter Hazard.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36566-genus-lifesciences-oxycodone-oral-solution-recall-particulate-matter-hazard. Based on FDA recall #D-0231-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0231-2021%22&limit=1).
Why it’s dangerous
Foreign particles were found in multiple lots of the product. If these particles enter the bloodstream during use, they could cause serious injury or health complications.
Who’s affected
Prescription opioid users who have the recalled oxycodone oral solution units. People with the specific NDC numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check the NDC number on the product label: 64950-354-05 for unit dose cups. The affected lots have specific expiration dates and serial numbers listed in the recall notice.
- Brand
Genus Lifesciences- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using any recalled oxycodone oral solution units with the listed NDC numbers and expiration dates.
Questions people ask
What is the specific product being recalled?
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05.
How can I tell if I have a recalled product?
Check the NDC number on the product label: 64950-354-05. The affected lots have specific expiration dates and serial numbers listed in the recall notice.
What should I do if I have the recalled product?
Immediately stop using the product and contact Genus Lifesciences for further instructions.
Contact Genus Lifesciences
We’ve drafted a message you can send Genus Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall D-0231-2021 — Genus Lifesciences Genus Lifesciences Hello, I own a Genus Lifesciences that is covered by recall D-0231-2021 from Genus Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0231-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0231-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.