Important Notice Regarding Compounded Porcine Thyroid Products

Effective December 1, 2025, Infuserve America will cease compounding porcine (pork-derived) thyroid products. This decision is necessitated by recent regulatory action from the U.S. Food and Drug Administration (FDA) clarifying the legal status of Animal-Derived Thyroid (ADT) products

Action Required for Patients:

Please consult with your provider to determine an alternative, synthetic thyroid product that will best meet your needs.

The FDA is providing a transition period for patients currently using these products, believing it will require up to 12 months to safely transition patients to an FDA-approved thyroid hormone replacement product. This ensures patients have sufficient time to work with their healthcare providers. Approved alternatives, such as synthetic liothyronine sodium (LT3) and synthetic levothyroxine sodium (LT4), are available and determined to be safe and effective for the treatment of hypothyroidism

Infuserve Pharmacist Support for Dose Transition

Infuserve Pharmacists are available to assist the provider with any dose conversion recommendations to facilitate a safe and accurate transition to an FDA-approved thyroid hormone replacement product.

For more information, please refer to the regulatory context provided by the FDA:
FDA Notice to Industry Regarding Animal-Derived Thyroid Products (August 6, 2025)

For additional regulatory details, please refer to the FDA’s post:
FDA Actions Address Unapproved Thyroid Medications