Estradiol Vaginal Inserts — Class II drug recall D-0350-2019
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2019-01-16, distributed nationwide. Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
| Recall number | D-0350-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2018-12-26 |
| Classified | 2019-01-08 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 96,240 applicators |
| Reason classes | device malfunction |
| NDC | 68462-0711, 68462-0711-71, 68462-0711-88 |
| Expiration dates | 2019-12-31, 2020-01-31, 2020-02-29 |
Product
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
Reason for recall
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0350-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.