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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

Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: July 2, 2025
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Summary

Metoprolol Succinate Extended-Release Tablets (25 mg) are being recalled because they failed to meet dissolution acceptance criteria during stability testing. The recall affects 27,648 100-count bottles and 5,376 500-count bottles. When a medication fails dissolution tests, it may not release the active ingredient into the body as intended, which can affect the drug's performance.

Risk

If the tablets do not dissolve properly, the medication may not reach effective levels in the bloodstream, potentially leading to inadequate treatment of the condition for which it was prescribed. No injuries or adverse events related to this issue have been reported to date.

What You Should Do

  1. This recall affects Metoprolol Succinate Extended-Release Tablets (25 mg) sold in 100-count bottles (NDC 70010-780-01) and 500-count bottles (NDC 70010-780-05) under lot numbers 1400008A and 1400008B 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 Granules Pharmaceuticals Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Metoprolol Succinate Extended-Release Tablets, USP (25 mg)
Variants: 25 mg, Tablet
Lot Numbers:
1400008A (Exp 12/31/2025)
1400008B (Exp 12/31/2025)
NDC:
70010-780-01
70010-780-05

Quantity: 27,648 100-count Bottles; 5,376 500-count Bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97131
Status: Active
Manufacturer: Granules Pharmaceuticals Inc.
Sold By: Pharmacies nationwide
Manufactured In: India, United States
Units Affected: 27,648 100-count Bottles; 5,376 500-count Bottles
Distributed To: Nationwide
Agency Last Updated: July 8, 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.