Class IIReported 2025-07-09

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,

Recalled by Granules Pharmaceuticals Inc.

Reason for Recall

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

Recall Number

D-0510-2025

Classification

Class II

Status

Ongoing