Reported Jan 15, 2025 · Terminated
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules…
Granules Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Granules Pharmaceuticals Inc. · 3701 Concorde Pkwy · Chantilly, VA · 20151-1126
Is this the product you have?
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only
- Manufactured byGranules India Limited, Hyderabad- 500 081, India
- Manufactured forQuallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
- Lot codes and dates
- Lot #: 4911311A, Exp
- Date11/2025
- Amount recalled
- 6,804 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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