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.
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,
Lot numbers, UPCs & expiration codes
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0510-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 24, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0510-2025, exactly as published.
Show all FDA fields
- City
- Chantilly
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97131
- Address
- 3701 Concorde Pkwy
- Code information
- Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
- Postal code
- 20151-1126
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0510-2025
- Classification
- Class II
- Recalling firm
- Granules Pharmaceuticals Inc.
- Product quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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,
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 24, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2025