Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 50090-1494
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 50090-1494). A significant event, classified as Class II, was initiated on Feb 25, 2025 by A-s Medication Solutions. The reported reason for this action was: "Presence of Foreign Tablets/Capsules."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Foreign Tablets/Capsules.
Feb 25, 2025
Apr 02, 2025
411 180-count bottles
Recall Profile & Regulatory Data
Event ID
96313
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
A-S Medication Solutions LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in U.S.
Product Description
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Batch or Lot Expiration Information
Lot# 4260340; Exp.12/31/2025.
Affected Packages Involved in this Recall
50090-1494-3Product
50090-1494-4Product
50090-1494-0Product
50090-1494-1Product
50090-1494-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
