Bayer Recalls Medroxyprogesterone Acetate Due to Stability Issues
Bayer recalls 194.62 kg of Medroxyprogesterone acetate API (Lot 87100040) due to failed particle size stability specifications at the 60-month test point.
Recall notice
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Contact the company
What happened, in plain English
Bayer HealthCare Pharmaceuticals Inc. is recalling a specific lot of Medroxyprogesterone acetate, micronized active pharmaceutical ingredient. The recall was issued because the product failed stability specifications for particle size at the 60-month test point. This affects approximately 194.62 kg of the drug distributed in New York and California. Read more at govinfonow.com/recall/47452-bayer-healthcare-pharmaceuticals-inc-recalls-medroxyprogesterone-acetate-micronized-ep-usp.
Source Summary by GovInfoNow · govinfonow.com/recall/47452-bayer-healthcare-pharmaceuticals-inc-recalls-medroxyprogesterone-acetate-micronized-ep-usp · Updated October 13, 2026 · FDA enforcement record: FDA #D-807-2013
Cite this page
“Bayer Recalls Medroxyprogesterone Acetate Due to Stability Issues.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47452-bayer-healthcare-pharmaceuticals-inc-recalls-medroxyprogesterone-acetate-micronized-ep-usp. Based on FDA recall #D-807-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-807-2013%22&limit=1).
Why it’s dangerous
The hazard is that the particle size of the micronized drug fell out of specification at the 60-month mark. The record does not explain what specific health effects or safety risks result from this failed stability test.
Who’s affected
This recall involves an active pharmaceutical ingredient (API) rather than a finished consumer product, so it primarily affects pharmaceutical manufacturers or distributors who received this raw material. The record does not specify direct risks to individual patients.
How to tell if you have this one
Look for Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient packaged in 6.0 kg drums (labeled as 6,000 kg). The affected item is Lot 87100040 from Bayer Schering Pharma AG.
- Brand
Bayer- Category
Drug
Where it went and when
Where it was distributed
Distributed in California and New York.
FDA distribution: “NY, CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, New York.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-807-2013 (June 13, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-807-2013 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.