FDA Issues Class II Recall for FarmaKeio Testosterone and Combination Pellets Due to Potential Metal Particulate Contamination

The US Food and Drug Administration (FDA) has issued a Class II recall for multiple sterile testosterone and testosterone/triamcinolone acetonide subcutaneous pellets manufactured and distributed by FarmaKeio Outsourcing LLC, located in Southlake, Texas. The recall was initiated due to CGMP deviations related to the potential presence of metal particulate matter in the affected products. The voluntary recall, initiated on October 14, 2025, affects over 550 000 pellets spanning more than a dozen strengths and formulations, including regular release and combination hormone therapy products. Distribution was nationwide in the US and Antigua, and no press release has been issued to date.

The FDA officially classified the recall as Class II on October 29, 2025, indicating that use of these products may cause temporary or medically reversible adverse health effects, though the probability of serious harm is low. The affected products include testosterone pellets in strengths ranging from 25 mg to 200 mg, as well as combination pellets containing testosterone and triamcinolone acetonide in various ratios (e.g., 12.5MG/2.5MCG, 100MG/20MCG, 200MG/40MCG). The company identified potential metal contamination stemming from manufacturing deviations, though no adverse events have been publicly reported at the time of classification. Customers were notified via email.

These compounded hormone pellets are typically used in hormone replacement therapy (HRT) for people with testosterone deficiency, menopausal symptoms, and certain inflammatory conditions, in the case of combination products including triamcinolone acetonide, a corticosteroid. Pharmacists should identify and remove all affected lots listed under NDCs ranging from 73693-0363-01 to 73693-0402-01, and communicate with prescribing clinicians about the potential risk of metal particulate exposure. While the recall is precautionary, metal contaminants can lead to localized tissue reactions or inflammation if implanted. Safe handling, patient communication, and alternative treatment coordination are essential to ensure continued care during the recall.

Reference

FDA. Enforcement Report. October 29, 2025. Accessed October 30, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm