Estriol USP Micronized 5 G — Class II drug recall D-1284-2020
Terminated recall by TRIOVA PHARMACEUTICALS LLC, reported 2020-06-10, distributed nationwide. Failed impurities/ degradation specifications: Out of specification for organic impurities.
| Recall number | D-1284-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TRIOVA PHARMACEUTICALS LLC, Tulsa, OK, United States |
| Recall initiated | 2020-05-15 |
| Classified | 2020-06-01 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2023-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 210 grams |
| Reason classes | specification failure |
| NDC | 71092-9977-02 |
| Lot numbers | 17010401181119190927, 1701040118111919092725200122 |
| Expiration dates | 2020-12 |
Product
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Reason for recall
Failed impurities/ degradation specifications: Out of specification for organic impurities.
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-1284-2020. 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.