Hormone therapy can transform the aging experience—but patients taking it via one delivery method will want to know about a possible issue that could lead to risky exposure.
Nearly 5,000 Packages of Estrogen Medication Recalled Nationwide
Published on Feb. 24, 2025
There was a period of time when cancer-causing effects of hormone replacement therapy were a question, but for many patients the treatment has been backed with continued investigation in recent years. September 2024 research published in a journal of the American Medical Association called menopausal hormone therapy “the most effective treatment for the relief of hallmark menopausal symptoms”—and specified “vasomotor” symptoms, like hot flashes and night sweats, and “genitourinary” symptoms, that may be related to the bladder or pelvic floor, as issues for which patients commonly seek managed care from their doctors.
If you’ve taken estrogen to address such symptoms, you’ll want to beware of a recent recall that was just announced on a hormonal medication used to ease the symptoms many experience as they navigate this stage of life.
On February 21, the U.S. Food and Drug Administration (FDA) updated an existing recall on Estradiol Gel, a medication that is applied topically to be delivered transdermally (through the skin) to alleviate the intensity of menopause-related symptoms. (The Cleveland Clinic explains that estradiol is one of the three types of estrogen, and calls estradiol “the primary form of estrogen in your body during your reproductive years” and “the most potent form of estrogen.”)
The recalling firm is listed as Padagis US LLC in Minneapolis, MN, while the medication itself is manufactured by Padagis in Yeruham, Israel. The Padagis website lists company manufacturing locations in both the U.S. (in Minnesota) and Israel.
The FDA says 4,944 cartons of the gel, which is available via prescription, have been recalled nationwide. The recalled product details include:
- Estradiol Gel, 0.1%, 0.25 milligrams per gram (mg/g)
- 30 packets per carton
- Lot #193109
- Expiration Date: 07/31/2026
The FDA cites the reason for the recall as “Defective Container,” stating that some of the Estradiol packets may not be fully sealed, “potentially allowing for loss of Ethanol from the product.” The World Health Organization (WHO) lists ethanol in a recent catalog of essential medicines, categorizing it under the Antiseptics section.
The recall, which was originally posted on February 6, was categorized last Friday as a Class II event, which “involves products that may cause temporary or medically reversible adverse health effects” according to the FDA’s three recall classification definitions.
Estradiol can go by brand names like Divigel, Elestrin, or EstroGel, and is prescribed to increase estrogen hormone levels in the body, according to the Cleveland Clinic, as a way of easing certain symptoms commonly connected with menopause. In addition to reducing both “the frequency and severity of hot flashes,” the Cleveland Clinic suggests the medication can also help with vaginal dryness or irritation or pain experienced during sex.
Contact your pharmacy or medical provider for assistance if you believe you have the recalled medication onhand.
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