Estradiol 25mg Pellet (Qualgen) – Quality Deviation (2017)
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
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
Brand
Qualgen
Lot Codes / Batch Numbers
Lot # C031, Exp. 03/2/18 Lot # B077, Exp. 08/10/17 Lot # B040, Exp. 05/16/17
Products Sold
Lot # C031; Exp. 03/2/18 Lot # B077; Exp. 08/10/17 Lot # B040; Exp. 05/16/17
Qualgen is recalling Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count due to CGMP deviations- Lack of Quality Assurance. 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
CGMP deviations- Lack of Quality Assurance
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