Medroxyprogesterone Acetate (Bayer) – Stability Failure (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
Brand
Bayer HealthCare Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot 87100040
Products Sold
Lot 87100040
Bayer HealthCare Pharmaceuticals Inc. is recalling Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, package due to Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.. 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
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
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, NY
Page updated: Jan 7, 2026