Specialty Process Labs Thyroid Product Recall: Subpotent Drug Risk
Specialty Process Labs recalls 0.5kg Thyroid USP Rx-only product due to subpotent drug risk. Affected units have specific NDC and lot numbers. Consumers should contact manufacturer for details.
Lower-risk recall
Subpotent Drug
Contact the company
What happened, in plain English
Specialty Process Labs is recalling a 0.5kg thyroid medication product for manufacturing use only because it may be subpotent. This means the product might not contain enough active ingredient to be effective for its intended purpose. Read more at govinfonow.com/recall/31552-specialty-process-labs-thyroid-product-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31552-specialty-process-labs-thyroid-product-recall-subpotent-drug-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0294-2026
Cite this page
“Specialty Process Labs Thyroid Product Recall: Subpotent Drug Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/31552-specialty-process-labs-thyroid-product-recall-subpotent-drug-risk. Based on FDA recall #D-0294-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0294-2026%22&limit=1).
Why it’s dangerous
The product is labeled as 'subpotent,' meaning it may not contain sufficient active ingredient to be effective for its intended use in manufacturing or repackaging. This could lead to ineffective medication if used in processes requiring precise potency.
Who’s affected
Manufacturers and processors who use this thyroid medication for repackaging or manufacturing. Those handling the product in a controlled environment are most at risk.
How to tell if you have this one
Check for the NDC number 81305-100-02 and lot number H22254-1XV on the product label. The product is for manufacturing, processing, or repackaging use only and expires January 31, 2027.
- Brand
Specialty Process Labs- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Specialty Process Labs at Phoenix, AZ 85034 for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 12 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe for regular medical use?
No, this product is intended for manufacturing, processing, or repackaging use only and not for direct human consumption.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0294-2026 (January 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0294-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.