Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Medroxyprogesterone acetate Recalled by Bayer HealthCare Pharmaceuticals Inc. Due to Failed Stability Specifications: Out of specification results for...

Date: June 13, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bayer HealthCare Pharmaceuticals Inc. directly.

Affected Products

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

Quantity: 194.62 kg

Why Was This Recalled?

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Where Was This Sold?

This product was distributed to 2 states: CA, NY

Affected (2 states)Not affected

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report