Estriol [ — Class II drug recall D-0628-2020
Terminated recall by Spectrum Laboratory Products, reported 2020-01-01, distributed nationwide. Subpotent Drug: Supplier indicated assay results did not meet specifications.
| Recall number | D-0628-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Laboratory Products, Gardena, CA, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2019-12-23 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2023-08-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 6.284 kilograms |
| Reason classes | potency |
| Lot numbers | 1HG0308, 1HH0630, 1HI0854, 4HL0005, 4HL0036, 4IH0032 |
| Expiration dates | 2021-04-16 |
Product
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
Reason for recall
Subpotent Drug: Supplier indicated assay results did not meet specifications.
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-0628-2020. 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.