Estradiol 12 — Class II drug recall D-0226-2019
Terminated recall by Qualgen, LLC, reported 2018-11-14, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0226-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualgen, LLC, Edmond, OK, United States |
| Recall initiated | 2018-10-17 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 69761-0012-01, 69761-0012-06, 69761-0012-12, 69761-0012-30 |
| Lot numbers | C236 |
| Expiration dates | 2018-11-13 |
Product
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Reason for recall
Lack of Assurance of Sterility
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-0226-2019. 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.