FDA recall D-0510-2025

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,

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.

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-06-24

Report date

2025-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chantilly, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2025