Class II
Ongoing
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,
This recall is currently active, issued July 9, 2025. It was issued by Granules Pharmaceuticals Inc..
- Company
- Granules Pharmaceuticals Inc.
- Recall Initiated
- June 24, 2025
- Posted
- July 9, 2025
- Recall Number
- D-0510-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Firm Location
- Chantilly, VA, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
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