US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jun 24, 2025 (15 months ago)

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

What was recalled

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 firm
Granules Pharmaceuticals Inc.
NDC code
70010-780-01
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0510-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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