Medroxyprogesterone acetate — Class III drug recall D-807-2013
Terminated recall by Bayer HealthCare Pharmaceuticals Inc., reported 2013-07-24, distributed in CA, NY. Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month
| Recall number | D-807-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer HealthCare Pharmaceuticals Inc., Morristown, NJ, United States |
| Recall initiated | 2013-06-13 |
| Classified | 2013-07-18 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2014-02-10 |
| Distributed | CA, NY |
| Quantity | 194.62 kilograms |
| Reason classes | specification failure |
| Lot numbers | 87100040 |
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
Reason for recall
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-807-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.