CLASS III Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report
Medroxyprogesterone acetate, micronized (EP recalled by Bayer HealthCare
Bayer HealthCare Pharmaceuticals is recalling Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, distributed in California, New York. The recall was initiated on 13 Jun 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-807-2013
- FDA event ID
- 65702
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Morristown, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Jun 2013
- FDA classified
- 18 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 13 Jun 2013 | Recall initiated by company | |
| 18 Jul 2013 | Classified by FDA | +35 days |
| 24 Jul 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
NY, CA
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Which lots are affected?
Lot 87100040
Where was it sold?
NY, CA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Medroxyprogesterone recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Medroxyprogesterone Acetate Injectable Suspension recalled | Mckesson Medical-Surgical Inc. Corporate Office | Potency & Assay | FL, MS |
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL recalledMedroxyprogesterone Acetate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Medroxyprogesterone Acetate 300 MG/ML Suspension vial recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension recalled | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension recalled | SUN Pharmaceutical Industries | Sterility | Nationwide |