Recalls / Class II
Class IID-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,
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 70010-780, 70010-781, 70010-782, 70010-783
- FDA application
- ANDA216916
- Affected lot / code info
- Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Why it was 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.
Recalling firm
- Firm
- Granules Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-06-24
- FDA classified
- 2025-07-08
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0510-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.