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Class II · ModerateActive recall

Metoprolol Succinate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGranules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151 foreign manufacturer
Brand nameMETOPROLOL SUCCINATE
Generic nameMETOPROLOL SUCCINATE
Active ingredient(s)METOPROLOL SUCCINATE
Distributed by / forGranules Pharmaceuticals Inc., Chantilly, VA 20151
NDC70010-780-01
Show the full FDA record
Full product labelMetoprolol 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,
Recalling firmGranules Pharmaceuticals Inc.
DistributionNationwide in the USA.
Quantity27,648 100-count Bottles; 5,376 500-count Bottles
Recall initiated2025-06-24
Report date2025-07-09
Recall completed—
Recall numberD-0510-2025
ClassificationClass II
FDA statusOngoing
Origin on fileChantilly VA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.