Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Ph
Summary
The FDA issued a Class II for Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackag by Specialty Process Labs LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0294-2026
Action Date
2026-01-28
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #H22254-1XV; Exp. 01/31/2027
Quantity Affected: 58 gms
Reason for Recall
Subpotent Drug
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-16
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 67 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Specialty Process Labs LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Specialty Process Labs LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Specialty Process Labs LLC have FDA actions?
Specialty Process Labs LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0294-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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