Bayer Recalls Estradiol Hemihydrate Powder Due to Contamination
Bayer HealthCare recalls Estradiol Hemihydrate M20 EP/USP Powder due to cross-contamination. Check lot numbers and distribution details.
Use caution until it’s fixed
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
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What happened, in plain English
Bayer HealthCare Pharmaceuticals Inc. is recalling Estradiol Hemihydrate M20 EP/USP Powder because it was cross-contaminated with another product. The affected items were packaged in 1.5 kg and 2.5 kg fiber drums and distributed to Kansas and California. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/48891-bayer-healthcare-pharmaceuticals-inc-recalls-estradiol-hemihydrate-m20-ep-usp.
Source Summary by GovInfoNow · govinfonow.com/recall/48891-bayer-healthcare-pharmaceuticals-inc-recalls-estradiol-hemihydrate-m20-ep-usp · Updated October 13, 2026 · FDA enforcement record: FDA #D-1433-2012
Cite this page
“Bayer Recalls Estradiol Hemihydrate Powder Due to Contamination.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48891-bayer-healthcare-pharmaceuticals-inc-recalls-estradiol-hemihydrate-m20-ep-usp. Based on FDA recall #D-1433-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1433-2012%22&limit=1).
Why it’s dangerous
The powder poses a hazard because it was cross-contaminated with another product during manufacturing or packaging. This contamination could compromise the purity and safety of the pharmaceutical ingredient if used as intended.
Who’s affected
This recall affects entities that purchased Rx-only pharmaceutical ingredients from Bayer, specifically those who received shipments in Kansas and California. The risk is primarily to manufacturers or facilities using this active ingredient for further processing.
How to tell if you have this one
Look for Estradiol Hemihydrate M20 EP/USP Powder packaged in 1.5 kg or 2.5 kg fiber drums. The specific lot number to check is 81202450, with an expiration date of 06/15/16. The product Art. No. is 165811.
- Brand
Bayer- Category
Drug
Where it went and when
Where it was distributed
Distributed in California and Kansas.
FDA distribution: “Kansas and California.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Kansas.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How much product was recalled?
A total of 112.295 kg of the powder was included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1433-2012 (May 8, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1433-2012 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.