Estradiol — Class II drug recall D-0881-2017
Terminated recall by Spectrum Laboratory Products, Inc., reported 2017-06-14, distributed nationwide. CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from th
| Recall number | D-0881-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Laboratory Products, Inc., New Brunswick, NJ, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2017-06-02 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2019-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 48 containers |
| Reason classes | cgmp |
| Lot numbers | 2FH0257, 2GA0254 |
| Expiration dates | 2017-09-30, 2018-03-24 |
Product
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.
Reason for recall
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
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-0881-2017. 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.