CLASS II Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Estradiol Tablets, USP, 2 mg recalled by Epic Pharma
Epic Pharma is recalling Estradiol Tablets, USP, 2 mg, distributed nationwide in the US. The recall was initiated on 4 Dec 2018 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-0297-2019
- FDA event ID
- 81729
- Recalling firm
- Epic Pharma, Laurelton, NY
- Brand
- Estradiol
- Manufacturer
- EPIC PHARMA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2018
- FDA classified
- 14 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 4 Dec 2018 | Recall initiated by company | |
| 14 Dec 2018 | Classified by FDA | +10 days |
| 26 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Product as listed by the FDA
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Estradiol Tablets, USP, 2 mg recalled?
Yes. Epic Pharma recalled Estradiol Tablets, USP, 2 mg on 4 Dec 2018. The recall is Class II and its status is Terminated. Recall number D-0297-2019.
Why was it recalled?
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Which lots are affected?
Lot #: 18103A, Exp 6/20
Where was it sold?
U.S.A. 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 21 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 Epic Pharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol tablets, 5 mg recalled by Epic PharmaEstradiol | Epic Pharma | Other | Nationwide |
Other Estradiol recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 1%, 25 mg per packet, 30 packets recalledEstradiol | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Estradiol Gel, 1%, 25 mg/g, 30 packets recalled by Padagis US | Padagis US | Packaging Defects | Nationwide |
| Drug | CLASS III | Estradiol Transdermal System, USP (Twice-Weekly) 0375mg/day recalledEstradiol | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS III | Estradiol Transdermal System, USP (Twice-Weekly) 025mg/day recalledEstradiol | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS II | Estradiol Tablets USP, 5MG, Tx Only recalled by Cardinal HealthcareEstradiol | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |