FDA Drugs recall ·
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg… recall
- Recall number
- D-0510-2025
- Date
- (initiated June 24, 2025)
- Company / brand
- Granules Pharmaceuticals Inc.
3701 Concorde Pkwy, Chantilly, VA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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,
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0510-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.