Metoprolol Succinate Tablet, Film Coated, Extended Release
FDA Recall NDC 70010-780
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metoprolol Succinate (NDC 70010-780). A significant event, classified as Class II, was initiated on Jun 24, 2025 by Granules Pharmaceuticals Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Jun 24, 2025
Jul 09, 2025
27,648 100-count Bottles; 5,376 500-count Bottles
Recall Profile & Regulatory Data
Event ID
97131
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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,
Batch or Lot Expiration Information
Lot# a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Affected Packages Involved in this Recall
70010-780-01Product
70010-780-05Product
70010-780-10Product
70010-781-01Product
70010-781-05Product
70010-781-10Product
70010-782-01Product
70010-782-05Product
70010-782-10Product
70010-783-01Product
70010-783-05Product
70010-783-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
