01/26/2026 | Press release | Distributed by Public on 01/26/2026 16:21
| Item 8.01 |
Other Matters. |
On January 26, 2026, F.H. Investments, Inc. ("Asteria Health"), a 503B manufacturer of compounded bioidentical hormones and wholly-owned subsidiary of biote Corp. (the "Company"), out of an abundance of caution initiated a voluntary recall of specific lots of hormone pellets shipped by Asteria Health between May 20, 2025 and January 19, 2026 due to the potential presence of metal particulate matter. The Company has notified affected practitioners of the voluntary recall. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (the "FDA").
While it is too early to ascertain the total cost of the voluntary recall, the Company expects to record a one-timecharge of approximately $1.3M to its fourth quarter cost of products related to write-offof impacted Company pellet inventory. The Company will likely incur some additional costs related to the recall in 2026 which are currently estimated to be approximately $1.0M. The Company does not believe that its fourth quarter business was impacted by the recall beyond the impact of the inventory write-off.The Company does not anticipate the recall will materially impact its ability to provide pellets to its practitioner partners or the ability of practitioners to service patients. More details on the potential financial impact of this event will be provided when the Company reports its fourth quarter results.