Medications & Supplements/Prescription Drugs

Genus Lifesciences Inc.: Oxycodone Hydrochloride Oral Solution Recalled for Foreign Particulate Matter

Agency Publication Date: January 11, 2021

Summary

Approximately 1,171,550 unit dose cups of Oxycodone Hydrochloride Oral Solution (5 mg/5mL) manufactured by Genus Lifesciences Inc. are being recalled due to the presence of foreign particulate matter found in multiple lots. This prescription pain medication was distributed nationwide in the USA in individual dose cups packaged in cases of 40 or 50. Consumers who have these products should stop using them and consult a healthcare professional, as the presence of unknown particles in a liquid medication can pose serious health risks.

Risk

The presence of foreign substance or particulate matter in an oral liquid medication can cause irritation or injury to the digestive tract or other internal tissues, and may interfere with the intended efficacy of the drug.

What You Should Do

Check your medication packaging for Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups with NDC 64950-354-05, Case NDC 64950-354-450, or Case NDC 64950-354-55.
Identify if your product matches any of the following lot numbers and expiration dates: 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); or 35400520A, 35400620A (Exp 1/31/22).
Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance regarding alternative treatment.
Return any unused unit dose cups to the pharmacy or place of purchase to receive a refund.
Contact Genus Lifesciences Inc. at their Allentown, Pennsylvania location for further instructions regarding this recall.
For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups

Model:

NDC 64950-354-05

Case NDC 64950-354-450

Case NDC 64950-354-55

Lot Numbers:

35400119A (Exp 12/31/20)

35400219A (Exp 12/31/20)

35400319A (Exp 12/31/20)

35400419A (Exp 12/31/20)

35400519A (Exp 12/31/20)

35400619A (Exp 12/31/20)

35400719A (Exp 1/31/21)

35400819A (Exp 1/31/21)

35400919A (Exp 2/28/21)

35401019A (Exp 2/28/21)

35401119A (Exp 2/28/21)

35401219A (Exp 4/30/21)

35401319A (Exp 4/30/21)

35401419A (Exp 5/31/21)

35401519A (Exp 5/31/21)

35401619A (Exp 5/31/21)

35401719A (Exp 7/31/21)

35401819A (Exp 7/31/21)

35401919A (Exp 8/31/21)

35402019A (Exp 8/31/21)

35402119A (Exp 9/30/21)

35402219A (Exp 9/30/21)

35402319A (Exp 9/30/21)

35402419A (Exp 9/30/21)

35402519A (Exp 10/31/21)

35402619A (Exp 11/30/21)

35402719A (Exp 11/30/21)

35400120A (Exp 12/31/21)

35400220A (Exp 12/31/21)

35400320A (Exp 12/31/21)

35400420B (Exp 12/31/21)

35400520A (Exp 1/31/22)

35400620A (Exp 1/31/22)

Date Ranges: EXP 12/31/20, EXP 1/31/21, EXP 2/28/21, EXP 4/30/21, EXP 5/31/21, EXP 7/31/21, EXP 8/31/21, EXP 9/30/21, EXP 10/31/21, EXP 11/30/21, EXP 12/31/21, EXP 1/31/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87044

Status: Resolved

Manufacturer: Genus Lifesciences Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1,171,550 cups

Distributed To: Nationwide

Agency Last Updated: January 15, 2021

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups with NDC 64950-354-05, Case NDC 64950-354-450, or Case NDC 64950-354-55.

Identify if your product matches any of the following lot numbers and expiration dates: 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); or 35400520A, 35400620A (Exp 1/31/22).

Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance regarding alternative treatment.

Return any unused unit dose cups to the pharmacy or place of purchase to receive a refund.

Contact Genus Lifesciences Inc. at their Allentown, Pennsylvania location for further instructions regarding this recall.

For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups

Model:

NDC 64950-354-05

Case NDC 64950-354-450

Case NDC 64950-354-55

Lot Numbers:

35400119A (Exp 12/31/20)

35400219A (Exp 12/31/20)

35400319A (Exp 12/31/20)

35400419A (Exp 12/31/20)

35400519A (Exp 12/31/20)

35400619A (Exp 12/31/20)

35400719A (Exp 1/31/21)

35400819A (Exp 1/31/21)

35400919A (Exp 2/28/21)

35401019A (Exp 2/28/21)

35401119A (Exp 2/28/21)

35401219A (Exp 4/30/21)

35401319A (Exp 4/30/21)

35401419A (Exp 5/31/21)

35401519A (Exp 5/31/21)

35401619A (Exp 5/31/21)

35401719A (Exp 7/31/21)

35401819A (Exp 7/31/21)

35401919A (Exp 8/31/21)

35402019A (Exp 8/31/21)

35402119A (Exp 9/30/21)

35402219A (Exp 9/30/21)

35402319A (Exp 9/30/21)

35402419A (Exp 9/30/21)

35402519A (Exp 10/31/21)

35402619A (Exp 11/30/21)

35402719A (Exp 11/30/21)

35400120A (Exp 12/31/21)

35400220A (Exp 12/31/21)

35400320A (Exp 12/31/21)

35400420B (Exp 12/31/21)

35400520A (Exp 1/31/22)

35400620A (Exp 1/31/22)

Date Ranges: EXP 12/31/20, EXP 1/31/21, EXP 2/28/21, EXP 4/30/21, EXP 5/31/21, EXP 7/31/21, EXP 8/31/21, EXP 9/30/21, EXP 10/31/21, EXP 11/30/21, EXP 12/31/21, EXP 1/31/22