Almost 20,000 Women’s Hormone Medications Recalled Nationwide

If you’re on a hormone medication, chances are that’s to regulate a very specific and essential physiological process related to your reproductive system, whether it’s pregnancy (or the prevention of it), female cancer, to address menopause symptoms, or otherwise.

For some patients taking progesterone, the U.S. Food and Drug Administration (FDA) has alerted the public to a recall affecting 19,872 units of injectible progesterone treatment in vial delivery. The National Institutes of Health explains that the medication, known as medroxyPROGESTERone Acetate Injectable Suspension, “is indicated only for the prevention of pregnancy.”

However, note that some forms of MedroxyPROGESTERone acetate may also be used in the treatment of other conditions related to women’s reproductive health, such as endometriosis, a condition in which tissue similar to the lining of the uterus grows outside the uterus; and polycystic ovarian syndrome (PCOS), among other things.

In vitro fertilization (IVF) patients may also take progesterone orally and/or subcutaneously. Though it is not immediately clear from the recall report whether the quality deviations could affect the outcome of IVF treatments, many patients (and doctors) would agree that any interruption in treatment protocol can be distressing.

An injectible form of progesterone is also sometimes used to treat various forms of cancer, including uterine cancer, kidney cancer, and breast cancer in post-menopausal women.

As a contraceptive, MedroxyPROGESTERone Acetate is delivered by injection typically every three months. As the Mayo Clinic explains, it works by preventing the ovaries from releasing an egg, and thickens cervical mucus to keep sperm from reaching the egg. This form of progesterone also inhibits the secretion of gonadotropins, which helps to prevent follicular maturation and thins the uterus to prevent implantation.

The recall was initiated after the FDA discovered deviations from Current Good Manufacturing Practices (CGMP), a set of regulations used to product quality, safety, and efficacy. The recall notice did not state exactly how the products deviated from those quality control standards.

The FDA has categorized this as a Class II recall: “A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” However, for someone taking this hormone to prevent pregnancy, this deviation from quality standards could potentially pose some risk.

The affected injections, distributed by Eugia US, LLC, of East Windsor, New Jersey, and manufactured by Eugia Pharma Specialties Limited, an India-based company, were available by prescription only. It’s reported they were packaged in single-dose vials of 150 milligrams per milliliter (mg/mL), 1 milliliter (mL) and are marked with the following identifying features:

• Lot Number: 1MP24069
• Expiration Date: August 2026

If you believe you may have been prescribed the affected hormone medication, ask your doctor whether you may need an alternative.

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