FDA Reports Class II Recall of Subpotent Thyroid USP Bulk Drug Distributed Nationwide

Key Takeaways

• Specialty Process Labs LLC has voluntarily recalled a bulk thyroid USP prescription drug used for manufacturing or repackaging, distributed nationwide under NDC 81305-100-02.
• The US Food and Drug Administration (FDA) classified the action as a Class II recall after the product was found to be subpotent, posing a risk of temporary or medically reversible adverse health effects.
• Thyroid USP is indicated for thyroid hormone replacement in patients with hypothyroidism, where accurate potency is essential for proper dosing.

Specialty Process Labs LLC has initiated a voluntary nationwide recall of thyroid USP, a prescription-only bulk drug substance used strictly for manufacturing, processing, or repackaging purposes. The recalled product is labeled with NDC 81305-100-02, packaged as 0.50 kg net weight, with a recalled quantity of 58 grams. It was manufactured by Specialty Process Labs in Phoenix, Arizona. The affected product is identified under Lot #H22254-1XV with an expiration date of January 31, 2027, and is associated with recall number D-0294-2026 and Event ID 98307. Distribution occurred nationwide in the US, and the recall remains ongoing. 

The FDA has classified this action as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall was firm-initiated and voluntary, with initial notification to consignees conducted via letter. The recall was initiated on January 16, 2026, and the FDA assigned its center classification on January 21, 2026. No press release has been issued for this recall at this time.

The recall was prompted by findings that the product was subpotent, meaning it did not meet labeled strength specifications. Subpotency in thyroid drug products raises concerns for downstream manufacturers and patients, as it may lead to inadequate dosing if incorporated into finished dosage forms. No termination date has been set, and no update history is currently available. 

Thyroid USP is a natural thyroid hormone preparation derived from porcine thyroid glands and is indicated for the treatment of hypothyroidism, including conditions such as primary, secondary, or tertiary hypothyroidism, and for thyroid hormone replacement or supplementation. Accurate potency is critical, as insufficient thyroid hormone levels can result in persistent hypothyroid symptoms, while variability in strength can complicate dose titration and patient management.