Estradiol Pellets (Qualgen) – Sterility Concern (2015)
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 USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
Brand
Qualgen
Lot Codes / Batch Numbers
Lots: A002 Exp.: 10/23/2015, A003 Exp.: 10/25/2015, A009 Exp.: 11/01/2015, A011 Exp.: 11/2/2015, A014 Exp.: 11/8/2015, A016 Exp.: 11/10/2015, A027 Exp.: 11/20/2015, A028 Exp.: 11/21/2015, A030 Exp.: 11/22/2015, A032 Exp.: 11/23/2015, A037 Exp.: 11/24/2015, A039 Exp.: 11/27/2015, A042 Exp.: 11/28/2015, A044 Exp.: 11/29/2015, A050 Exp.: 12/06/2015, A051 Exp.: 12/10/2015, A053 Exp.: 12/12/2015, A062 Exp.: 12/20/2015, A065 Exp.: 12/28/2015
Products Sold
Lots: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009 Exp.: 11/01/2015; A011 Exp.: 11/2/2015; A014 Exp.: 11/8/2015; A016 Exp.: 11/10/2015; A027 Exp.: 11/20/2015; A028 Exp.: 11/21/2015; A030 Exp.: 11/22/2015; A032 Exp.: 11/23/2015; A037 Exp.: 11/24/2015; A039 Exp.: 11/27/2015; A042 Exp.: 11/28/2015; A044 Exp.: 11/29/2015; A050 Exp.: 12/06/2015; A051 Exp.: 12/10/2015; A053 Exp.: 12/12/2015; A062 Exp.: 12/20/2015; A065 Exp.: 12/28/2015
Qualgen is recalling Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 due to Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on st. 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: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility 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