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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 6,804
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:
Related recalls
Same manufacturer · Granules Pharmaceuticals Inc.
See all →- HighTrazodone tablets recalled over the presence of foreign tablets
FDA (Drugs) · 2026-02-11
- ModerateAmphetamine extended-release capsules 10 mg recalled over failed degradation specifications
FDA (Drugs) · 2025-10-01
- ModerateAmphetamine extended-release capsules 15 mg recalled after impurity testing failure
FDA (Drugs) · 2025-10-01
- ModerateAmphetamine extended-release capsules 20 mg recalled over impurity and degradation results
FDA (Drugs) · 2025-10-01
- ModerateAmphetamine extended-release capsules 30 mg recalled after failing impurity specifications
FDA (Drugs) · 2025-10-01
Same hazard · foreign tablet
See all →- HighAmphetamine salt tablets recalled after bottles contained a lower strength tablet
FDA (Drugs) · 2025-09-17
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- HighLisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
FDA (Drugs) · 2025-07-23
- ModeratePregabalin Capsules Recalled Due to Foreign Tablet Contamination During Packaging
FDA (Drugs) · 2024-06-12
- HighIbuprofen and Famotidine Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2024-01-24
Similar recalls
- HighGabapentin 600 mg Tablets Recalled Due to Metformin Contamination
FDA (Drugs) · 2024-08-14
- HighMetformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-04-02
- SevereCaraco Recalls Metformin HCl ER Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2014-03-05
- SevereGranules Pharmaceuticals Recalls Metformin Hydrochloride Extended-Release Tablets
FDA (Drugs) · 2020-07-22
- ModerateAurobindo Recalls Metformin Hydrochloride Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2018-02-28
- ModerateSun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Matter
FDA (Drugs) · 2018-07-25