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 Failures

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

Summary

Viatris Inc. is recalling 560,785 bottles of Mylan Levothyroxine Sodium Tablets because tests found the medication may be too strong (superpotent) or too weak (subpotent). This recall affects multiple dosage strengths and both 90-count and 1000-count bottles. When a medication does not have the correct potency, it may not effectively treat the patient's condition or could cause unintended side effects. These products were distributed nationwide throughout the United States and Puerto Rico.

Risk

Taking medication that is stronger or weaker than prescribed can cause thyroid levels to become unbalanced. Subpotent tablets may fail to treat hypothyroidism, while superpotent tablets could lead to symptoms of an overactive thyroid, such as rapid heartbeat, anxiety, or weight loss.

What You Should Do

  1. This recall affects Mylan brand Levothyroxine Sodium Tablets in dosage strengths including 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg.
  2. Identify your medication by checking the NDC codes (ranging from 0378-1800-77 to 0378-1823-10) and lot numbers on your prescription bottle. Affected expiration dates range from November 2024 to September 2025. 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 the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions regarding this recall.

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, 125 mcg
Variants: 125 mcg, Tablet
Lot Numbers:
3182797 (Exp. Nov 2024)
8177587
3199816 (Exp. Jun 2025)
NDC:
0378-1813-77
0378-1813-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 137 mcg
Variants: 137 mcg, Tablet
Lot Numbers:
8165919 (Exp. Dec 2024)
8172050 (Exp. Mar 2025)
8183251 (Exp. Sept 2025)
3185542 (Exp. Dec 2024)
3192838 (Exp. Mar 2025)
3208172 (Exp. Sept 2025)
NDC:
0378-1823-77
0378-1823-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 150 mcg
Variants: 150 mcg, Tablet
Lot Numbers:
8177720 (Exp. Jun 2025)
3200218 (Exp. Jun 2025)
NDC:
0378-1815-77
0378-1815-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 175 mcg
Variants: 175 mcg, Tablet
Lot Numbers:
3192915
8172108 (Exp. Mar 2025)
3208680 (Exp. Sep 2025)
NDC:
0378-1817-77
0378-1817-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 200 mcg
Variants: 200 mcg, Tablet
Lot Numbers:
8179847 (Exp. July 2025)
3203518 (Exp. July 2025)
NDC:
0378-1819-77
0378-1819-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 25 mcg
Variants: 25 mcg, Tablet
Lot Numbers:
8181875 (Exp. Aug 2025)
8174497 (Exp. April 2025)
3209099 (Exp. Sep 2025)
3206534 (Exp. Aug 2025)
3196137 (Exp. April 2025)
NDC:
0378-1800-77
0378-1800-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 50 mcg
Variants: 50 mcg, Tablet
Lot Numbers:
8174701 (Exp. April 2025)
8182228 (Exp. Aug 2025)
3193984 (Exp. Mar 2025)
3206790 (Exp. Aug 2025)
NDC:
0378-1803-77
0378-1803-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 75 mcg
Variants: 75 mcg, Tablet
Lot Numbers:
8177078 (Exp. May 2025)
8168596 (Exp. Jan 2025)
3199313 (Exp. May 2025)
3194118 (Exp. Mar 2025)
3186238 (Exp. Dec 2024)
3209590 (Exp. Sep 2025)
3199317 (Exp. May 2025)
3188733 (Exp. Jan 2025)
NDC:
0378-1805-77
0378-1805-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 88 mcg
Variants: 88 mcg, Tablet
Lot Numbers:
8180781 (Exp. Aug 2025)
3191628 (Exp. Feb 2025)
3197139 (Exp. Apr 2025)
3188976 (Exp. Jan 2025)
3184929 (Exp. Dec 2024)
3204909 (Exp. Aug 2025)
NDC:
0378-1807-77
0378-1807-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 100 mcg
Variants: 100 mcg, Tablet
Lot Numbers:
8171269 (Exp. Feb 2025)
8179579 (Exp. July 2025)
3183815 (Exp. Nov 2024)
3189147 (Exp. Jan 2025)
3192027 (Exp. Feb 2025)
3202894 (Exp. Jul 2025)
3192026 (Exp. Feb 2025)
3199781 (Exp. Jun 2025)
3192028 (Exp. Feb 2025)
3202895 (Exp. July 2025)
NDC:
0378-1809-77
0378-1809-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Product: Levothyroxine Sodium Tablets USP, 112 mcg
Variants: 112 mcg, Tablet
Lot Numbers:
8171623 (Exp. Feb 2025)
8164486 (Exp. Nov 2024)
3205462 (Exp. Aug 2025)
3192428 (Exp. Feb 2025)
3184096 (Exp. Nov 2024)
NDC:
0378-1811-77
0378-1811-10

Packaged in 90-count and 1000-count bottles. Manufactured for Mylan Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95768
Status: Active
Manufacturer: Viatris Inc
Sold By: Retail Pharmacies; Hospitals
Manufactured In: United States
Units Affected: 11 products (92,512 bottles; 118,324 bottles; 9,828 bottles; 19, 549 bottles; 55,032 bottles; 34,845 bottes; 42,331 bottles; 63,077 bottles; 43,765 bottles; 65,169; 35,883 bottles)
Distributed To: Nationwide
Agency Last Updated: December 16, 2024

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.