October 17, 2019
Epic Pharma is recalling more than 11,000 bottles of estradiol tablets, 0.5 mg, after a 1-mg tablet was discovered in a bottle, according to the October 16, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall is for 100-count bottles (NDC 42806-087-01) from lot 19094A (Exp. 2021), which were distributed throughout the United States.
Epic Pharma voluntarily initiated the recall September 26, 2019. On October 9, 2019, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Estradiol is a prescription hormone used to treat symptoms of menopause in women, treat people with prostate or breast cancer, and prevent osteoporosis.