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Lower risk Drug recall · FDA · Published September 26, 2019

Epic Pharma recalls Estradiol 0.5 mg tablets: Foreign 1 mg tablets found

Epic Pharma recalls 100-count Estradiol 0.5 mg tablets (Rx only) due to foreign 1 mg tablets found in some bottles. No remedy stated in official notice.

🇺🇸 FDA recall #D-0135-2020DrugEpic Pharma ›
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Recalling firmEpic Pharma, LLC22715 N Conduit Ave · Laurelton, NY 11413-3134
✎ GovInfoNow plain-language explainer

Epic Pharma is recalling 100-count bottles of Estradiol 0.5 mg tablets (prescription only) because some bottles contain foreign 1 mg tablets. This could cause confusion or incorrect dosing if taken without proper medical supervision. Read more at govinfonow.com/recall/37902-epic-pharma-recalls-estradiol-0-5-mg-tablets-foreign-1.

Source Summary by GovInfoNow · govinfonow.com/recall/37902-epic-pharma-recalls-estradiol-0-5-mg-tablets-foreign-1 · Updated October 5, 2026 · FDA enforcement record: FDA #D-0135-2020

Cite this page

“Epic Pharma recalls Estradiol 0.5 mg tablets: Foreign 1 mg tablets found.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37902-epic-pharma-recalls-estradiol-0-5-mg-tablets-foreign-1. Based on FDA recall #D-0135-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0135-2020%22&limit=1).

Epic Pharma, LLC voluntarily recalled Estradiol tablets, 0.5 mg, 100-count bottles due to the presence of foreign tablets, according to the FDA. The Food and Drug Administration announced the recall on September 26, 2019.

How to tell if you have it

  • Brand: Epic Pharma
  • Product: Estradiol tablets, 0.5 mg, 100-count bottles, Rx only
  • NDC: 42806-087-01
  • Lot #: 19094A
  • Expiration: 2021
  • Distribution: Nationwide within the United States
  • Units affected: 11,472 bottles

The hazard

Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets, according to the FDA.

Context

GovInfoNow's records show Epic Pharma, LLC has one other recall on record since December 4, 2018, involving a foreign tablet found in Estradiol 2 mg tablets. Other recent recalls of similar products include Annora Pharma Pitavastatin Tablets 2mg Recall (February 3, 2026), Golden State Baclofen Tablets Recall (November 26, 2025), and Granules Pharmaceuticals Trazodone 50mg Recall (January 26, 2026).

How to tell if you have this one

Check for the product name 'Estradiol 0.5 mg tablets', 100-count bottles, and the lot number 19094A (expiring 2021) distributed by Epic Pharma.

  • Brand
    Epic Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 19094A on the bottle label to confirm if it's part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

1. Firm started the recall: Sep 26, 201912. FDA classified it Class II: Oct 9, 201923. Published in FDA’s Enforcement Report: Oct 16, 201934. FDA terminated the recall: May 31, 2023420192023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0135-2020 (September 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0135-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.