Oxycodone Oral Solution (Genus) – Foreign Substance (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Genus Lifesciences Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Genus Lifesciences Inc. is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. due to Presence of Foreign Substance: Particulate matter was found in multiple lots of product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026