Metformin ER 500 mg tablets recalled due to foreign tablet contamination
Granules Pharmaceuticals is recalling Metformin ER 500 mg tablets due to discovery of a Paracetamol tablet in one bottle. Patients taking the affected lot should verify their medication with their pharmacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as Class II. Although no illnesses or injuries have been reported, the presence of a foreign medication tablet in a prescription bottle represents a risk-of-harm product where unintended medication exposure could occur.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling Metformin ER 500 mg tablets (Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg) due to contamination with a foreign tablet. A Paracetamol 500 mg tablet was found in a 1000-count bottle of the recalled medication.
The affected product is identified by Lot #4911311A with an expiration date of 11/2025. Approximately 6,804 bottles were distributed to a distributor in Ohio.
If a patient inadvertently takes the Paracetamol tablet along with their prescribed Metformin, this could result in unintended medication exposure. No illnesses or injuries have been reported in connection with this recall.
Patients who have received this product should verify their medication with their pharmacy to confirm they have the correct product. Anyone with questions should contact their healthcare provider or pharmacist.
The recalled product
- Product
- METFORMIN ER 500 MG (METFORMIN ER 500 MG)
- Brand
- METFORMIN ER 500 MG
- Manufacturer
- Granules Pharmaceuticals Inc.
- Category
- Drug
- Hazard
- foreign-tablet
- medication-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 4911311A
- Exp. Date: 11/2025
UPCs (2)
- 0382009117102
- 0382009118017
Distribution
Distributed in 1 state:
- OH
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