CLASS II Drug recall · Reported 8 Aug 2012 · FDA Enforcement Report
Estradiol Hemihydrate M20 EP/USP Powder recalled by Bayer HealthCare
Bayer HealthCare Pharmaceuticals is recalling Estradiol Hemihydrate M20 EP/USP Powder, distributed in California, Kansas. The recall was initiated on 8 May 2012 and the FDA has classified it as Class II.
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-1433-2012
- FDA event ID
- 62651
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 May 2012
- FDA classified
- 31 Jul 2012
- Reported
- 8 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 8 May 2012 | Recall initiated by company | |
| 31 Jul 2012 | Classified by FDA | +84 days |
| 8 Aug 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Where it was distributed
Kansas and California.
Questions about this recall
Why was it recalled?
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Which lots are affected?
Lot Number: 81202450, Exp 06/15/16
Where was it sold?
Kansas and California.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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