biote Corp. 8-K

What Happened
biote Corp.’s wholly owned compounding subsidiary, F.H. Investments, Inc. (doing business as Asteria Health), on January 26, 2026 initiated a voluntary recall of specific lots of compounded bioidentical hormone pellets shipped between May 20, 2025 and January 19, 2026 due to the potential presence of metal particulate matter. The company has notified affected practitioners and is conducting the recall with the knowledge of the U.S. Food and Drug Administration (FDA).

Key Details

• Recall initiated: January 26, 2026; affected shipments dated May 20, 2025–January 19, 2026.
• Expected one-time charge: approximately $1.3 million recorded to fourth-quarter cost of products for write-off of impacted inventory.
• Additional estimated recall-related costs in 2026: approximately $1.0 million.
• Company statement: does not expect the recall to materially impact its ability to supply pellets to practitioners or to service patients; more financial detail to be disclosed with Q4 results.

Why It Matters
The recall creates an immediate, identifiable financial hit (the ~$1.3M Q4 write-off plus ~ $1.0M estimated 2026 costs) that will affect near-term results and will be reflected in biote’s upcoming quarterly reporting. FDA awareness raises regulatory oversight risk, although the company currently says supply and patient care should not be materially disrupted. Investors should watch biote’s fourth-quarter filings and subsequent updates for final costs, any broader operational impact, and potential regulatory developments.