Estradiol Vaginal Inserts (Glenmark) – applicator defect (2019)
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 Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Brand
Glenmark Pharmaceuticals Inc., USA
Lot Codes / Batch Numbers
Batch numbers: a) 20180514, 20180544, Apr-2020, 20180545, 20180546, 20180588, May-2020, 20190003, Jun-2020, b) 20180515, 20180543, Apr-2020, 20180587, May-2020
Products Sold
Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020
Glenmark Pharmaceuticals Inc., USA is recalling Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable appli due to Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.. 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
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
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