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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

Accord Healthcare Levothyroxine Sodium Tablets Recalled for Subpotency

Agency Publication Date: April 30, 2025
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Summary

Accord Healthcare, Inc. is recalling 33,629 bottles of Levothyroxine Sodium Tablets, USP, because the medication is subpotent. Subpotency means the tablets contain less than the required amount of active ingredient (levothyroxine sodium), which may affect how well the medication works. The recall includes four different strengths of the medication (25 mcg, 50 mcg, 88 mcg, and 112 mcg) sold in 90-count or 1000-count bottles.

Risk

Taking subpotent thyroid medication can lead to inadequate treatment of hypothyroidism, potentially causing symptoms like fatigue, weight gain, depression, and sensitivity to cold to return or worsen. No specific reports of injuries or adverse events were mentioned in the recall data.

What You Should Do

  1. This recall affects Levothyroxine Sodium Tablets, USP, in 25 mcg, 50 mcg, 88 mcg, and 112 mcg strengths distributed nationwide in the United States.
  2. Identify your medication by checking the bottle label for the following NDC codes: 16729-447-17, 16729-448-17, 16729-450-17, or 16729-452-15.
  3. Verify if your bottle is part of the recall by checking for lot numbers D2300323 (Exp 01/2026), D2400547 (Exp 02/2026), D2300044 (Exp 12/2025), or D2400725 (Exp 03/2026).
  4. 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 Accord Healthcare, Inc. for further instructions.
  5. 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:

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, 25 mcg (0.025 mg)
Variants: 25 mcg, Tablet
Lot Numbers:
D2300323 (Exp 01/2026)
NDC:
16729-447-17

1000 count bottles; Manufactured by Intas Pharmaceuticals Limited.

Product: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg)
Variants: 50 mcg, Tablet
Lot Numbers:
D2400547 (Exp 02/2026)
NDC:
16729-448-17

1000 count bottles; Manufactured by Intas Pharmaceuticals Limited.

Product: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg)
Variants: 88 mcg, Tablet
Lot Numbers:
D2300044 (Exp 12/2025)
NDC:
16729-450-17

1000 count bottles; Manufactured by Intas Pharmaceuticals Limited.

Product: Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg)
Variants: 112 mcg, Tablet
Lot Numbers:
D2400725 (Exp 03/2026)
NDC:
16729-452-15

90 count bottles; Manufactured by Intas Pharmaceuticals Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96666
Status: Active
Manufacturer: ACCORD HEALTHCARE, INC.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 4 products (4,888 Bottles; 4,872 Bottles; 4,885 Bottles; 18,984 Bottles)
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.