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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

Syntec Pharma Corp: Thyroid Powder Recalled Due to Inconsistent Active Ingredient Levels

Agency Publication Date: October 11, 2018
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Summary

Syntec Pharma Corp is recalling approximately 488 units (including 2 drums and 486 kg) of Thyroid Powder USP active pharmaceutical ingredient. The product was found to have inconsistent levels of the active ingredients levothyroxine and liothyronine, which could result in patients receiving too much or too little medication. This recall affects Thyroid Powder distributed in Alabama and Texas for use in prescription compounding.

Risk

Inconsistent levels of active ingredients in thyroid medication can lead to serious health complications, as patients may receive dosages that are significantly higher or lower than prescribed, potentially causing symptoms of hyperthyroidism or hypothyroidism.

What You Should Do

  1. Identify if you have the affected Thyroid Powder USP by checking for product labels that include Recall # D-0013-2019 (Full Strength) or Recall # D-0014-2019, both manufactured by Sichuan Friendly Pharmaceutical Co., Ltd.
  2. Check your inventory for all lots of this product, including 5 KG bags and 25 KG bags distributed by Syntec Pharma Corp.
  3. If you are a compounding pharmacist or medical provider, stop using these ingredients for prescription compounding immediately.
  4. If you are a patient taking a compounded thyroid medication, contact your healthcare provider or pharmacist immediately to determine if your prescription was made using the affected Thyroid Powder.
  5. Return any unused raw Thyroid Powder to the place of purchase for a refund and contact Syntec Pharma Corp at 96 Gazza Blvd, Farmingdale, NY 11735 for further instructions.
  6. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: THYROID POWDER USP, Full Strength (5 KG bag)
Model:
D-0013-2019
CAS No. 50809-32-0
Lot Numbers:
All lots
Product: THYROID POWDER USP (25 KG bag)
Model:
D-0014-2019
CAS No. 50809-32-0
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81128
Status: Resolved
Manufacturer: Syntec Pharma Corp
Sold By: Syntec Pharma Corp; Rx Compounding pharmacies
Manufactured In: China, United States
Units Affected: 2 products (2 drums; 486 kg)
Distributed To: Alabama, Texas

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.