Estriol — Class II drug recall D-0651-2020
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-0651-2020 |
|---|---|
| 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 | 42.12 gm |
| Reason classes | specification failure |
| NDC | 76420-0049-37 |
| Lot numbers | 04171902, 05201901, 08121902, 08161901, 10111903, 10161901, 11061803, 11061901, 11211904, 11281804, 11291804 |
| Expiration dates | 2020-12-31, 2021-05-31, 2021-08-31 |
Product
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
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-0651-2020. 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.