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,
Reported: July 9, 2025 Initiated: June 24, 2025 #D-0510-2025
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.
Details
- Recalling Firm
- Granules Pharmaceuticals Inc.
- Units Affected
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Distribution
- Nationwide in the USA.
- Location
- Chantilly, VA
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by Granules Pharmaceuticals Inc.. Units affected: 27,648 100-count Bottles; 5,376 500-count Bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 9, 2025. Severity: Moderate. Recall number: D-0510-2025.
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