Asteria Health Estradiol Pellets Recalled Over Potential Metal Contamination

Key Clinical Summary

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of estradiol sterile pellets (6 mg to 37.5 mg), involving over 118 000 units distributed nationwide, with expiration dates from February to October 2026.
• The recall was initiated by Asteria Health due to the potential presence of metal particulate matter, a manufacturing defect that may pose a temporary or medically reversible safety risk upon implantation.
• Estradiol pellets are used in hormone replacement therapy (HRT) to manage estrogen deficiency symptoms, typically administered via subcutaneous insertion in clinical settings.

The FDA has issued a Class II recall for multiple strengths of estradiol sterile pellets manufactured by F.H. Investments, Inc. (dba Asteria Health) in Birmingham, Alabama. The recall affects over 118 000 sterile pellets across ten strengths (ranging from 6 mg to 37.5 mg), identified under various NDC codes and lot numbers, with expiration dates from February to October 2026. The recall was initiated on January 26, 2026, due to the potential presence of metal particulate matter, a manufacturing quality concern that can pose safety risks if implanted.

The recall was officially classified by the FDA as Class II on February 11, 2026, meaning that while the issue is unlikely to cause serious adverse health consequences, it may result in temporary or medically reversible health effects. Asteria Health voluntarily initiated the recall and notified its consignees through formal letters. No adverse events or injuries have been reported to date, and no public press release has been issued. The products were distributed nationwide within the United States and are used in hormone replacement therapy settings.

Estradiol pellets are commonly used in hormone replacement therapy (HRT) for the treatment of symptoms associated with menopause, estrogen deficiency, or hypogonadism, delivered via subcutaneous implantation. Pharmacists and clinicians should identify and quarantine affected lot numbers, including those associated with 6 mg, 10 mg, 12.5 mg, 15 mg, 18 mg, 20 mg, 22 mg, 25 mg, and 37.5 mg strengths, and ensure patients are not implanted with potentially contaminated pellets. 

Reference
FDA. Enforcement Report. February 11, 2026. Accessed February 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm