Estradiol Hemihydrate M20 EP/USP Powder — Class II drug recall D-1433-2012
Terminated recall by Bayer HealthCare Pharmaceuticals Inc., reported 2012-08-08, distributed in CA, KS. Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross con
| Recall number | D-1433-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ, United States |
| Recall initiated | 2012-05-08 |
| Classified | 2012-07-31 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2012-12-18 |
| Distributed | CA, KS |
| Quantity | 112.295 kilograms |
| Lot numbers | 81202450 |
| Expiration dates | 2016-06-15 |
Product
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Reason for recall
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
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-1433-2012. 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.