Drug 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.
Lots and codes
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Recall details
- Recalling firm
- Granules Pharmaceuticals Inc., Chantilly, VA
- Quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 24, 2025
Related products
- Metoprolol Succinate – drug information
- NDC 70010-780 Metoprolol Succinate · Metoprolol Succinate 25 mg/1 · Granules Pharmaceuticals Inc.
- NDC 70010-781 Metoprolol Succinate · Metoprolol Succinate 50 mg/1 · Granules Pharmaceuticals Inc.
- NDC 70010-783 Metoprolol Succinate · Metoprolol Succinate 200 mg/1 · Granules Pharmaceuticals Inc.
- NDC 70010-782 Metoprolol Succinate · Metoprolol Succinate 100 mg/1 · Granules Pharmaceuticals Inc.