Estradiol Vaginal Inserts USP — Class II drug recall D-0156-2020
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2019-11-06, distributed nationwide. Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
| Recall number | D-0156-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2019-10-22 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2021-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 216,840 cartons |
| NDC | 68462-0711, 68462-0711-71, 68462-0711-88 |
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.
Reason for recall
Defective Delivery System: complaints for difficulty in pushing the 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-0156-2020. 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.