Estradiol Gel Recalled Due to Defective Container

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for estradiol gel, 0.1%, 0.25 mg. The affected batch has been identified as Lot 245226005B (expiring April 2028), containing 2592 cartons.
• The recall was initiated by Amneal Pharmaceuticals, LLC due to a defective container, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Estradiol gel is used to treat hot flashes and vaginal dryness.

The FDA has issued a Class II recall for estradiol gel, 0.1%, 0.25 mg, affecting 2592 cartons. This product is being recalled by Amneal Pharmaceuticals, LLC based in Bridgewater, New Jersey. The recall was initiated on September 8, 2026, and received a Class II classification on September 28, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after packets of the product were discovered to be either empty or partially full. This issue affects Lot 245226005B, which will expire in April 2028. Amneal Pharmaceuticals has sent out a public notice via letter; no press release has been issued for this recall.

Estradiol gel is a used to prevent and treat hot flashes among women experiencing menopause. It can also be used to treat vaginal dryness, itching, and burning. Pharmacists should identify and quarantine Lot 245226005B, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 7, 2026. Accessed October 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222723