Lower riskDrug recall · FDA · Published December 4, 2018
Epic Pharma Estradiol Tablets Recall: Foreign Tablet Found in Bottle
Epic Pharma recalls 100-count Estradiol 2 mg tablets due to a foreign tablet found in some bottles. This is a safety issue for patients using prescription hormone therapy.
“Epic Pharma Estradiol Tablets Recall: Foreign Tablet Found in Bottle.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39392-epic-pharma-estradiol-tablets-recall-foreign-tablet-found-in-bottle. Based on FDA recall #D-0297-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0297-2019%22&limit=1).
The FDA announced on Dec. 4, 2018, that Epic Pharma LLC voluntarily recalled Estradiol Tablets, USP, 2 mg, due to the presence of a foreign tablet. The recall affects 2,976 bottles distributed nationwide.
The hazard involves the presence of a foreign tablet or capsule. A single foreign tablet was found in a pharmacy-dispensed bottle of 30 Estradiol 2 mg tablets.
Context
GovInfoNow's records show Epic Pharma, LLC has one other recall on record since Sept. 26, 2019. Other recent recalls of similar products include Annora Pharma Pitavastatin Tablets 2mg Recall (Feb. 3, 2026), Golden State Baclofen Tablets Recall (Nov. 26, 2025), and Granules Pharmaceuticals Trazodone 50mg Recall (Jan. 26, 2026).
How to tell if you have this one
Check for the product name 'Estradiol Tablets, USP, 2 mg, 100-count bottle' with NDC 42806-089-01 and lot number 18103A, which expires June 2020.
Brand
Epic Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Product
Look for the NDC 42806-089-01 and lot number 18103A on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0297-2019 (December 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0297-2019 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.