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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

Mylan Levothyroxine Sodium Tablets Recalled for Super-Potency

Agency Publication Date: March 20, 2025
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Summary

Mylan Institutional, Inc. is recalling 1,415 cartons of Levothyroxine Sodium Tablets (levothyroxine sodium) in 150 mcg and 125 mcg strengths. The recall was initiated because testing showed the tablets were super-potent, meaning they contain more of the active thyroid medication than specified. 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 Mylan Institutional, Inc. for further instructions.

Risk

Taking medication with higher potency than prescribed can lead to hyperthyroidism, which may cause an irregular heartbeat, increased blood pressure, and other hormonal complications. No incidents or injuries have been reported to date regarding this specific recall.

What You Should Do

  1. The recalled products are Mylan Levothyroxine Sodium Tablets, USP, in 150 mcg and 125 mcg strengths, packaged in cartons containing 100-unit dose blister cards.
  2. Identify the 150 mcg tablets by checking for NDC 51079-445-20, lot 3116074, and expiration date 09/30/2025. Identify the 125 mcg tablets by checking for NDC 51079-443-20, lot 3115773, and expiration date 03/31/2025.
  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 Mylan Institutional, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (150 mcg)by Mylan Pharmaceuticals Inc.
Variants: 150 mcg (0.15 mg), 100 Unit Dose Blister Cards
Lot Numbers:
3116074 (Exp. 09/30/2025)
NDC:
51079-445-20

Recall #: D-0290-2025; Quantity: 347 Cartons

Product: Levothyroxine Sodium Tablets, USP (125 mcg)by Mylan Pharmaceuticals Inc.
Variants: 125 mcg (0.125 mg), 100 Unit Dose Blister Cards
Lot Numbers:
3115773 (Exp. 03/31/2025)
NDC:
51079-443-20

Recall #: D-0291-2025; Quantity: 1,068 cartons

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96428
Status: Active
Manufacturer: Mylan Institutional, Inc.
Sold By: Mylan Institutional, Inc.
Manufactured In: India, United States
Units Affected: 2 products (347 Cartons; 1,068 cartons)
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.