CLASS II Drug recall · Reported 16 Oct 2019 · FDA Enforcement Report
Estradiol tablets, 0.5 mg recalled by Epic Pharma
Epic Pharma is recalling Estradiol tablets, 0.5 mg, distributed nationwide in the US. The recall was initiated on 26 Sep 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-0135-2020
- FDA event ID
- 83849
- Recalling firm
- Epic Pharma, Laurelton, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2019
- FDA classified
- 9 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 26 Sep 2019 | Recall initiated by company | |
| 9 Oct 2019 | Classified by FDA | +13 days |
| 16 Oct 2019 | Published in enforcement report | +7 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 Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Product as listed by the FDA
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Which lots are affected?
Lot #: 19094A, Exp. 2021
Where was it sold?
Nationwide within the United States
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 6 Oct 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, USP, 2 mg recalled by Epic Pharma | Epic Pharma | Other | Nationwide |
Other Estradiol recalls
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Estradiol, 6 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 22 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 18 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol,15 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |