Metformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
A-S Medication Solutions is recalling 411 bottles of Metformin Hydrochloride Extended-Release 500mg tablets (Lot #4260340) distributed nationwide due to the presence of foreign tablets or capsules.
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: This is an FDA Class II recall involving contamination with foreign tablets in prescription medication—a risk-of-harm product. No reported illnesses or injuries are mentioned in the source, meeting the criteria for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
A-S Medication Solutions is recalling Metformin Hydrochloride Extended-Release 500mg tablets (NDC 50090-1494-3) due to the presence of foreign tablets or capsules in affected bottles.
The recall affects 411 bottles of Lot #4260340 with an expiration date of 12/31/2025. The product was distributed nationwide in the United States.
Patients using this medication should contact their pharmacy or healthcare provider regarding their specific supply. Do not use medication from the affected lot without consulting a healthcare provider first.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- A-S Medication Solutions LLC
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# 4260340
- Exp.12/31/2025.
Distribution
Distributed nationwide across the United States.
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