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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Macleods Levothyroxine Sodium Tablets Recalled for Foreign Substance

Agency Publication Date: June 12, 2025
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Summary

Macleods Pharmaceuticals Ltd has recalled 1,344 bottles (1000-count each) of Levothyroxine Sodium Tablets, USP (112 mcg). The recall was initiated after a foreign substance—a black hair—was found embedded inside a tablet. This prescription medication is used to treat hypothyroidism and should meet strict purity standards.

Risk

The presence of a foreign object like a hair in a tablet is a manufacturing defect that poses a risk of contamination. While the immediate health risk is considered low, foreign material in prescription medication is a violation of safety and quality standards.

What You Should Do

  1. This recall affects Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg) sold in 1000-count bottles under NDC 33342-398-44.
  2. Check your medication bottle for lot number MLF2401A and an expiration date of 01/31/2026.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Macleods Pharmaceuticals Ltd for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg)
Variants: 112 mcg (0.112mg), 1000-count bottle, Tablet
Lot Numbers:
MLF2401A (Exp 01/31/2026)
NDC:
33342-398-44

Manufactured for Macleods Pharma USA, Inc. Princeton, NJ; Manufactured by Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96979
Status: Active
Manufacturer: Macleods Pharmaceuticals Ltd
Sold By: Pharmacies
Manufactured In: India
Units Affected: 1,344- 1000 count bottles
Distributed To: Nationwide

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 · 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.