Testosterone Pellets Recalled Over Potential Contamination

Key Clinical Summary

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm‑initiated Class II recall of multiple Asteria Health testosterone sterile pellets, including single‑ingredient testosterone and combination pellets with anastrozole or triamcinolone acetonide, distributed nationwide with expiration dates through September 2026.
• The recall was initiated by F.H. Investments, Inc. (dba Asteria Health) due to the potential presence of metal particulate matter, a manufacturing defect that may cause temporary or medically reversible health effects.
• Testosterone pellets are implantable hormone therapies indicated for testosterone replacement in patients with hypogonadism, commonly used in outpatient hormone replacement therapy settings.

The FDA has issued a Class II recall for multiple strengths of testosterone sterile pellets, including single-ingredient testosterone (12.5 mg to 303 mg) and combination pellets containing anastrozole or triamcinolone acetonide, manufactured by F.H. Investments, Inc. (dba Asteria Health) in Birmingham, Alabama. The recall affects hundreds of thousands of pellets distributed nationwide in the USA, across numerous lot numbers with expiration dates ranging from April through September 2026. The recall was initiated on January 26, 2026, due to the potential presence of metal particulate matter, classified as a foreign substance.

The FDA classified the recall as Class II on February 11, 2026, indicating that exposure may cause temporary or medically reversible adverse health effects, though serious outcomes are unlikely. The recall was voluntarily initiated by Asteria Health after identifying the potential for metal contamination during manufacturing. Notification was provided to consignees via letter, and no public press release has been issued. The contamination concern applies to both testosterone-only pellets and combination hormone pellets containing anastrozole or triamcinolone acetonide.

Testosterone pellets are used in hormone replacement therapy (HRT) for patients with testosterone deficiency or hypogonadism, delivered via subcutaneous implantation. Combination pellets with anastrozole are used to manage estrogen balance during testosterone therapy, while those with triamcinolone acetonide may provide anti-inflammatory effects. Pharmacists and clinicians should review inventory for the affected lot numbers and ensure that potentially contaminated pellets are not implanted. 

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