Estradiol Hemihydrate Powder (Bayer HealthCare) – Cross Contamination (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bayer HealthCare Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot Number: 81202450, Exp 06/15/16
Products Sold
Lot Number: 81202450, Exp 06/15/16
Bayer HealthCare Pharmaceuticals Inc. is recalling Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, A due to Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, KS
Page updated: Jan 7, 2026