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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

Levothyroxine Sodium Tablets Recalled for Subpotency

Agency Publication Date: October 6, 2025
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Summary

Accord Healthcare, Inc. is recalling 54,432 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) because testing found the medication's potency fell below approved levels over time. Levothyroxine Sodium is a prescription drug used to treat an underactive thyroid (hypothyroidism). This recall affects 90-count bottles nationwide that were manufactured for Accord Healthcare by Intas Pharmaceuticals Limited.

Risk

The medication is subpotent, meaning it may not provide the full prescribed dose of the hormone. This could lead to a recurrence of hypothyroidism symptoms, such as fatigue, weight gain, and cold intolerance, because the patient is not receiving the expected therapeutic level of the drug.

What You Should Do

  1. Identify if you have the affected medication by checking the bottle for NDC 16729-450-15 and Lot # D2300045 with an expiration date of 12/31/2025.
  2. 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.
  3. 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 (90 Tablets per bottle)
Variants: 88 mcg (0.088 mg), Rx Only
Lot Numbers:
D2300045 (Exp 12/31/2025)
NDC:
16729-450-15

Manufactured for Accord Healthcare, Inc. by Intas Pharmaceuticals Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97613
Status: Active
Manufacturer: ACCORD HEALTHCARE, INC.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 54,432 bottles
Distributed To: Nationwide
Agency Last Updated: October 14, 2025

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.