FDA Recalls Subpotent Thyroid Drug Ingredient from Specialty Process Labs
Specialty Process Labs is recalling thyroid USP ingredient due to subpotency—the active ingredient is below the required strength. The affected batch was distributed nationwide and is used in manufacturing, processing, or repackaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported hospitalizations or illnesses. The hazard—subpotency in a thyroid ingredient—is a risk-of-harm scenario where inadequate potency could lead to insufficient therapeutic effect, but without reported adverse events, it qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Specialty Process Labs LLC is recalling a batch of Thyroid, USP, a pharmaceutical ingredient, due to subpotency. The recalled product is Lot #H22254-1XV (expiring 01/31/2027) and was distributed nationwide. This ingredient is intended for use in manufacturing, processing, or repackaging.
Subpotency means the ingredient contains less active ingredient than required by the United States Pharmacopeia standard. Products manufactured using this subpotent ingredient could contain less thyroid hormone than intended, potentially resulting in inadequate therapeutic effect.
This is a voluntary recall initiated by the manufacturer on January 16, 2026. Entities that received this ingredient should stop using it and contact Specialty Process Labs. Patients with questions about their thyroid medications should speak with their healthcare provider.
The recalled product
- Product
- Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
- Manufacturer
- Specialty Process Labs LLC
- Category
- Drug — Thyroid
- Hazard
- subpotent-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #H22254-1XV
- Exp. 01/31/2027
Distribution
Distributed nationwide across the United States.
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