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Class II · ModerateRecall completed

Metformin Er 500 Mg

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

Does this affect you?
Check your lot numberLot #: 4911311A, Exp. Date: 11/2025
Where it was soldDistributor in OH.
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

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

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, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands foreign manufacturer
Brand nameMETFORMIN ER 500 MG
Generic nameMETFORMIN ER 500 MG
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forQuallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands
NDC82009-117-10
Show the full FDA record
Full product labelMetformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
Recalling firmGranules Pharmaceuticals Inc.
DistributionDistributor in OH.
Quantity6,804 bottles
Recall initiated2024-12-30
Report date2025-01-15
Recall completed2026-01-15
Recall numberD-0192-2025
ClassificationClass II
FDA statusTerminated
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.