D-0510-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2025
- Initiation Date
- June 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
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,
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 Pattern
Nationwide in the USA.
Code Information
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025