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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

Mayne Pharma Inc: Liothyronine Sodium Tablets Recalled Due to Failed Dissolution Testing

Agency Publication Date: November 29, 2017
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Summary

Mayne Pharma Inc. has recalled 11,364 bottles of Liothyronine Sodium Tablets (25 mcg), a prescription medication used to treat hypothyroidism, because the tablets failed dissolution specifications during testing. This failure means the medication may not dissolve properly in the body, which can prevent the patient from receiving the correct amount of active drug. These 100-count bottles were distributed nationwide within the United States under the Perrigo label. Consumers should contact their healthcare provider to discuss how this recall affects their treatment and to obtain a replacement prescription if necessary.

Risk

If the medication does not dissolve according to specifications, it may not be absorbed effectively by the body, potentially leading to under-treatment of thyroid conditions. This could result in symptoms of hypothyroidism returning or worsening, though no specific injuries or adverse events have been reported in this notice.

What You Should Do

  1. Identify your medication by checking the label for Liothyronine Sodium Tablets, USP 25 mcg in 100-count bottles with NDC 0574-0222-01.
  2. Check the bottle for Lot number 16F649 and an expiration date of May 2018 to confirm if your specific bottle is affected.
  3. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking the medication or switch to a new lot.
  4. Return any unused product from the affected lot to your pharmacy to request a refund or a replacement bottle.
  5. Contact Mayne Pharma Inc. at their Greenville, North Carolina location or through your pharmacy for further instructions regarding this voluntary recall.
  6. For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Liothyronine Sodium Tablets, USP (25 mcg, 100-count bottles)
Model:
NDC 0574-0222-01
Recall #: D-0098-2018
Lot Numbers:
16F649 (Exp: May 2018)
Date Ranges: May 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78544
Status: Resolved
Manufacturer: Mayne Pharma Inc
Sold By: Perrigo; pharmacies nationwide
Manufactured In: United States
Units Affected: 11,364 bottles
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.