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,

Recall Number: D-0510-2025

Firm: Granules Pharmaceuticals Inc.

Classification: Class II

Status: Ongoing

Report Date: 20250709

Initiation Date: 20250624

Termination Date:

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

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,