Estriol — Class II drug recall D-0652-2020
Terminated recall by Asclemed USA Inc. dba Enovachem Pharmaceuticals, reported 2020-01-15, distributed in CA. Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test resu
| Recall number | D-0652-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asclemed USA Inc. dba Enovachem Pharmaceuticals, Torrance, CA, United States |
| Recall initiated | 2019-12-09 |
| Classified | 2020-01-08 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2023-08-09 |
| Distributed | CA |
| Quantity | 56.4 gm |
| Reason classes | specification failure |
| NDC | 76420-0049-38 |
| Lot numbers | 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161901, 09161902, 10091905, 10221902, 10311901, 10311902, 11191804, 11211902, 12281802 |
| Expiration dates | 2020-12-31, 2021-05-31, 2021-08-31 |
Product
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Reason for recall
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
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-0652-2020. 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.