Drug FDA Class II Terminated Foreign material
Metformin 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
Granules Pharmaceuticals Inc. Published Jan 15, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 45/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Granules Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
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.
Hazards
Paracetamol tablet · primary
Affected products (1)
Metformin 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
METFORMIN ER 500 MG · 6,804 bottles
NDC: 82009-117, 82009-118, 82009-117-10, 82009-118-01
Code info: Lot #: 4911311A, Exp. Date: 11/2025
Affected areas
Ohio
Timeline
- InitiatedDec 30, 2024
- PublishedJan 15, 2025
- TerminatedJan 15, 2026
- Recall number
- D-0192-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.