Estradiol USP Bulk (Medisca) – cGMP 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, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
Brand
Medisca, Inc.
Lot Codes / Batch Numbers
a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B, b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E, 130941/G, 136108/A
Products Sold
a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B; b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E,130941/G, 136108/A,
Medisca, Inc. is recalling ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) due to cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection. 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; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
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