Granules Pharmaceuticals Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-cou
Recalled July 9, 2025 · FDA recall D-0510-2025 · Granules Pharmaceuticals
Hazard
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. · FDA Class II
Units
27,648 100-count Bottles; 5,376 500-count Bottles
Sold at
Nationwide in the USA.
Description
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
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,
Manufacturer(s)
Granules Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →