Class IIOngoing

Metoprolol Succinate Extended-Release Tablets recall

FDA recall D-0510-2025 · initiated Jun 24, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

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.

Details

Product: 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 by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Recalling company: Granules Pharmaceuticals Inc
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA.
Initiated: Jun 24, 2025
FDA report date: Jul 9, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0510-2025 ↗

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