CLASS II Drug recall · Reported 25 Dec 2019 · FDA Enforcement Report
Estriol, USP (Micronized), containers recalled by Medisca
Medisca is recalling Estriol, USP (Micronized), containers, distributed nationwide in the US. The recall was initiated on 25 Nov 2019 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-0622-2020
- FDA event ID
- 84357
- Recalling firm
- Medisca, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2019
- FDA classified
- 16 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 25 Nov 2019 | Recall initiated by company | |
| 16 Dec 2019 | Classified by FDA | +21 days |
| 25 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
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
Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L
Where was it sold?
Nationwide
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.
More recalls from Medisca
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Budesonide, USP (Micronized), 500 mg recalled by Medisca | Medisca | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estrone, USP Bulk, in a) 100 mgs recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol, USP Bulk (Hemihydrate), in a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
Other Estriol recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty recalled | Wedgewood Village Pharmacy | Processing Deviation | Nationwide |
| Drug | CLASS II | Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty recalled | Wedgewood Village Pharmacy | Processing Deviation | Nationwide |
| Drug | CLASS II | Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm, Rx recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Estriol, USP, (Micronized) recalled by Asclemed USA | Asclemed USA | Potency & Assay | CA |
| Drug | CLASS II | Estriol, USP, (Micronized) recalled by Asclemed USA | Asclemed USA | Potency & Assay | CA |