Estradiol Vaginal Inserts — Class II drug recall D-0620-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2018-03-28, distributed in PR. Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensi
| Recall number | D-0620-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-03-19 |
| Classified | 2018-04-06 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-10-15 |
| Distributed | PR |
| Quantity | 640,486 vaginal |
| Reason classes | packaging |
| NDC | 00093-3223, 00093-3223-08, 00093-3223-19, 00093-3223-97 |
| Expiration dates | 2018-12, 2019-01, 2019-05, 2019-07, 2019-09 |
Product
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.
Reason for recall
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from 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-0620-2018. 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.