Reported Jul 9, 2025 · Ongoing

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b)…

Granules Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Granules Pharmaceuticals Inc. · 3701 Concorde Pkwy · Chantilly, VA · 20151-1126

Is this the product you have?

  • Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only
  • Manufactured byGranules India Limited, Hyderadab-500 081, India
  • Manufactured forGranules Pharmaceuticals Inc., Chantilly, VA 20151
Lot codes and dates
  • Lot # a)1400008A
  • Exp Date
    • 12/31/2025
    • b) 1400008B
  • Exp Date12/31/2025
Amount recalled
27,648 100-count Bottles; 5,376 500-count Bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:06 PM UTC

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