Granules Pharmaceuticals Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-co…

Recall date

June 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0510-2025

FDA classification

Class II

Brand / firm

Granules Pharmaceuticals Inc.

Sold / distributed

Nationwide in the USA.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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,