Estradiol Vaginal Inserts USP 10 mcg — Class II drug recall D-1340-2019
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2019-06-19, distributed nationwide. Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
| Recall number | D-1340-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2019-06-03 |
| Classified | 2019-06-11 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2022-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 31,656 boxes |
| NDC | 68462-0711, 68462-0711-71, 68462-0711-88 |
| Lot numbers | 20180516 |
| Expiration dates | 2020-04-30 |
Product
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Reason for recall
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
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-1340-2019. 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.