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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 0.5 mg Tablets Recalled for Mislabeled Higher Dosage Tablets

Agency Publication Date: October 9, 2019
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Summary

Epic Pharma, LLC is recalling 11,472 bottles of Estradiol (0.5 mg), a generic hormone replacement medication. The recall was initiated because a bottle of the 0.5 mg tablets was found to contain a tablet of the higher 1 mg strength. If you take a 1 mg tablet instead of your prescribed 0.5 mg dose, you would be receiving double the intended medication. Consumers should immediately check their prescription bottles and contact their healthcare provider or pharmacist for guidance.

Risk

Taking a higher dose of hormone medication than prescribed can lead to unintended side effects or hormonal imbalances. In this case, a patient could accidentally ingest a 1 mg dose when they were prescribed a 0.5 mg dose due to the presence of foreign tablets in the bottle.

What You Should Do

  1. Check your medication bottle for Estradiol 0.5 mg tablets distributed by Epic Pharma, LLC (NDC 42806-087-01).
  2. Verify the Lot Number and Expiration Date on the label: look for Lot 19094A with an expiration date in 2021.
  3. If you identify an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement.
  4. Return any unused portions of the affected lot to your pharmacy for a refund and further instruction.
  5. Contact Epic Pharma, LLC at their Laurelton, NY facility for more information regarding this recall.
  6. For 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

๐Ÿ’ฐFull 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, 0.5 mg (100-count bottles)
Model:
NDC 42806-087-01
Recall #: D-0135-2020
Lot Numbers:
19094A (Exp. 2021)
Date Ranges: Expiration 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83849
Status: Resolved
Manufacturer: Epic Pharma, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 11,472 (bottles of 100)
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 ยท 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.