Estradiol Tablet
FDA Recall NDC 42806-088
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Estradiol (NDC 42806-088). A significant event, classified as Class II, was initiated on Sep 26, 2019 by Epic Pharma, Llc. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Sep 26, 2019
Oct 16, 2019
11,472 (bottles of 100)
Recall Profile & Regulatory Data
Event ID
83849
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Epic Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
May 31, 2023
Product Description
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
Batch or Lot Expiration Information
Lot# : 19094A, Exp. 2021
Affected Packages Involved in this Recall
42806-087-01Product
42806-087-05Product
42806-088-01Product
42806-088-05Product
42806-089-09Product
42806-089-01Product
42806-089-05Product
Class II Terminated
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Dec 04, 2018
Dec 26, 2018
2976 bottles
Recall Profile & Regulatory Data
Event ID
81729
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Epic Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Feb 09, 2021
Product Description
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Batch or Lot Expiration Information
Lot# : 18103A, Exp 6/20
Affected Packages Involved in this Recall
42806-087-01Product
42806-087-05Product
42806-088-01Product
42806-088-05Product
42806-089-09Product
42806-089-01Product
42806-089-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
