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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Epic Pharma, LLC: Estradiol 2 mg Tablets Recalled for Foreign Tablet Contamination

Agency Publication Date: December 14, 2018
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Summary

Epic Pharma, LLC is recalling 2,976 bottles of Estradiol Tablets (USP, 2 mg), a hormone replacement medication, after a single foreign tablet or capsule was found inside a pharmacy-dispensed bottle. This recall affects 100-count bottles of the prescription medication distributed nationwide. While only one incident has been reported, the presence of an incorrect medication in the bottle could lead to accidental ingestion of an unknown substance. Consumers who have these specific bottles should immediately verify their lot numbers and contact their pharmacist.

Risk

The presence of a foreign tablet means a patient might inadvertently consume the wrong medication, which could cause adverse health effects or lead to a lack of the intended treatment. One report was received where a foreign tablet was found in a bottle dispensed to a patient.

What You Should Do

  1. Check your medication bottle for Estradiol Tablets, USP, 2 mg in 100-count bottles with NDC 42806-089-01.
  2. Identify if your bottle is part of the recall by looking for Lot #: 18103A with an expiration date of 6/20 (June 2020).
  3. If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on obtaining a safe replacement.
  4. Return any unused or suspected product to the pharmacy where you purchased it for a refund.
  5. Contact the manufacturer, Epic Pharma, LLC, at their Laurelton, NY facility for further instructions regarding this recall.
  6. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Estradiol Tablets, USP, 2 mg (100-count bottle)
Model:
NDC 42806-089-01
Recall #: D-0297-2019
Lot Numbers:
18103A (Exp 6/20)
Date Ranges: Expiration June 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81729
Status: Resolved
Manufacturer: Epic Pharma, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2976 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.