US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 26, 2019 (7 years ago)

Estradiol tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.

What was recalled

Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01

Recalling firm
Epic Pharma, LLC
NDC code
42806-087-01
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0135-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Estradiol recalls

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Class II · Moderate risk Ongoing

Alyacen 7/7/7

Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Glenmark Pharmaceuticals Inc., USA NDC 68462-556-29 D-0588-2026
Class II · Moderate risk Ongoing

Estradiol Gel

Reason Defective Container; packets were found to be either empty or partially full.

ANI Pharmaceuticals, Inc. NDC 70954-531-20 D-0543-2026
Class II · Moderate risk Ongoing

Estradiol

Reason Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0315-2026
Class II · Moderate risk Ongoing

Estradiol

Reason Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0314-2026
Class II · Moderate risk Ongoing

Estradiol

Reason Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0313-2026