Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Metoprolol Succinate Extended-Release Tablets Recalled by Granules Pharmaceuticals Inc. Due to Failed Dissolution Specifications: Product failed to meet dissolution...

Date: June 24, 2025
Company: Granules Pharmaceuticals Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Granules Pharmaceuticals Inc. directly.

Affected Products

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,

Quantity: 27,648 100-count Bottles; 5,376 500-count Bottles

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Granules Pharmaceuticals Inc.

Granules Pharmaceuticals Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report