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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

S.P. Labs Thyroid Medication Recalled for Failed Stability Specifications

Agency Publication Date: April 18, 2024
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Summary

Specialty Process Labs LLC has recalled 243 units of S.P. Labs Thyroid (Full Strength and USP) products because they failed stability testing. These prescription thyroid medications were distributed in bulk quantities for manufacturing, processing, or repackaging and may not maintain their correct potency or quality through their expiration dates. No injuries or adverse events have been reported in connection with this recall.

Risk

Failed stability specifications mean the medication may not provide the correct dose of the active ingredient, potentially leading to ineffective treatment for thyroid conditions.

What You Should Do

  1. This recall affects S.P. Labs Thyroid, Full Strength and USP bulk products used for manufacturing or repackaging, sold under NDC numbers 81305-500-01, 81305-100-01, 81305-100-02, and 81305-100-03.
  2. Check the lot number and expiration date printed on the product label to determine if your inventory is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately for any manufacturing, processing, or repackaging activities.
  4. Contact Specialty Process Labs LLC or your distributor to arrange for the return of any remaining units.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: S.P. Labs Thyroid, Full Strength
Variants: 1.0 kg pack size
Lot Numbers:
H22212-FSV (Exp: 11/21/2024)
NDC:
81305-500-01

Rx only; For Manufacturing, Processing or Repackaging Use Only.

Product: S.P. Labs Thyroid, USP
Variants: 1.0 kg pack size, 0.5 kg pack size, 100g pack size
Lot Numbers:
L13152-1XV (Exp: 11/21/2024)
B10383-1XV (Exp: 02/14/2025)
B10453-1X (Exp: 02/15/2025)
C10803-1X (Exp: 03/23/2025)
E11363-1X (Exp: 05/18/2025)
K12753-1X (Exp: 10/12/2025)
L13103-1X (Exp: 11/13/2025)
NDC:
81305-100-01
81305-100-02
81305-100-03

Rx only; For Manufacturing, Processing or Repackaging Use Only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94268
Status: Resolved
Manufacturer: Specialty Process Labs LLC
Sold By: Specialty Process Labs LLC; Pharmaceutical distributors
Manufactured In: United States
Units Affected: 2 products (26 units; 217 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.