Granules Recalls Metoprolol Succinate 25mg Due to Dissolution Failure
Granules Pharmaceuticals recalls specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications in stability studies.
Use caution until it’s fixed
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Contact the company
What happened, in plain English
Granules Pharmaceuticals Inc. is recalling Metoprolol Succinate Extended-Release Tablets, USP, 25 mg due to failed dissolution specifications. The product did not meet acceptance criteria during long-term stability studies at the 6-month mark. This means the medication may not release or absorb properly as intended. Read more at govinfonow.com/recall/32013-granules-recalls-metoprolol-succinate-25mg-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/32013-granules-recalls-metoprolol-succinate-25mg-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0510-2025
Cite this page
“Granules Recalls Metoprolol Succinate 25mg Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32013-granules-recalls-metoprolol-succinate-25mg-due-to-dissolution-failure. Based on FDA recall #D-0510-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0510-2025%22&limit=1).
Why it’s dangerous
The tablets failed to meet dissolution acceptance criteria in stability studies conducted at 6 months under long-term storage conditions (25°C/60% RH). This failure suggests the drug might not release its active ingredient correctly, potentially leading to reduced effectiveness or unpredictable dosing for the patient.
Who’s affected
Patients currently taking Metoprolol Succinate Extended-Release Tablets, USP, 25 mg manufactured by Granules Pharmaceuticals Inc. are affected. Individuals who purchased the specific lots listed below are at risk of receiving a product that may not perform as expected.
How to tell if you have this one
Check your bottle for NDC 70010-780-01 (100-count) or NDC 70010-780-05 (500-count). Verify the lot numbers are either 1400008A or 1400008B, both with an expiration date of 12/31/2025. The product was distributed nationwide in the USA.
- Brand
Granules Pharmaceuticals- Category
Drug
What to do — step by step
Check your medication details
Verify if your Metoprolol Succinate tablets match the recalled NDCs, lot numbers (1400008A or 1400008B), and expiration date of 12/31/2025.
Contact your pharmacist or doctor
Speak with your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or switch to a different manufacturer.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Granules Pharmaceuticals recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0510-2025 (June 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0510-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.