Testosterone 37.5mg Pellet (Qualgen) – Sterility Risk (2018)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Brand
Qualgen, LLC
Lot Codes / Batch Numbers
Lots: C245 BUD: 11/28/2018, D005 BUD: 1/5/2019, D027 BUD: 1/31/2019, D035 BUD: 2/9/2019, D058 BUD: 3/9/2019
Products Sold
Lots: C245 BUD: 11/28/2018; D005 BUD: 1/5/2019; D027 BUD: 1/31/2019; D035 BUD: 2/9/2019; D058 BUD: 3/9/2019
Qualgen, LLC is recalling Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 6 due to Lack of Assurance of Sterility. 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
Lack of Assurance of Sterility
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