Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mylan Levothyroxine Sodium Tablets Recalled for Potency Issues

Agency Publication Date: December 12, 2024
Share:
Sign in to monitor this recall

Summary

Mylan Institutional, Inc. is recalling 7,515 cartons of Levothyroxine Sodium Tablets (levothyroxine) in various strengths because the medication may be subpotent (too weak) or superpotent (too strong). These prescription tablets are used to treat thyroid conditions and are sold in cartons containing 100 unit-dose blister cards. Taking medication that is not the correct strength can lead to ineffective treatment or dangerous levels of thyroid hormone in the body.

Risk

Subpotent or superpotent thyroid medication can cause uncontrolled thyroid levels, leading to serious health complications like hyperthyroidism or hypothyroidism. Potency deviations in thyroid drugs are particularly concerning because the body requires very precise levels of the hormone to function properly.

What You Should Do

  1. This recall affects Levothyroxine Sodium Tablets, USP, in strengths of 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, and 175 mcg manufactured for Mylan Pharmaceuticals Inc.
  2. Check the lot number and NDC (National Drug Code) printed on your medication carton or individual blister cards. See the Affected Products section below for the full list of affected codes.
  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) or visit www.fda.gov/safety/recalls for more information.

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 (100 mcg)
Variants: 100 mcg, Tablet
Lot Numbers:
3115936 (Exp 07/2025)
NDC:
51079-442-20

100 Tablets per carton (10 unit dose blister cards of 10 tablets each)

Product: Levothyroxine Sodium Tablets, USP (112 mcg)
Variants: 112 mcg, Tablet
Lot Numbers:
3115707 (Exp 02/2025)
NDC:
42292-039-20

100 Tablets per carton (10 unit dose blister cards of 10 tablets each)

Product: Levothyroxine Sodium Tablets, USP (125 mcg)
Variants: 125 mcg, Tablet
Lot Numbers:
3115893 (Exp 6/2025)
NDC:
51079-443-20

100 Tablets per carton (10 unit dose blister cards of 10 tablets each)

Product: Levothyroxine Sodium Tablets, USP (137 mcg)
Variants: 137 mcg, Tablet
Lot Numbers:
3115448 (Exp 12/31/2024)
3115732 (Exp 3/31/2025)
3116024 (Exp 9/30/2025)
NDC:
42292-041-20

100 Tablets per carton (10 unit dose blister cards of 10 tablets each)

Product: Levothyroxine Sodium Tablets, USP (150 mcg)
Variants: 150 mcg, Tablet
Lot Numbers:
3115924 (Exp 06/2025)
NDC:
51079-445-20

100 Tablets per carton (10 unit dose blister cards of 10 tablets each)

Product: Levothyroxine Sodium Tablets, USP (175 mcg)
Variants: 175 mcg, Tablet
Lot Numbers:
3115869 (Exp 03/2025)
NDC:
42292-040-20

100 Tablets per carton (10 unit dose blister cards of 10 tablets each)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95817
Status: Active
Manufacturer: Mylan Institutional, Inc.
Sold By: pharmacies; hospitals
Manufactured In: United States
Units Affected: 6 products (2,835 cartons; 988 cartons; 1,664 cartons; 1,133 cartons; 690 cartons; 205 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.