FDA Drug Recalls

Recalls / Class II

Class IID-0292-2025

Product

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

Brand name
Metformin Hydrochloride
Generic name
Metformin Hydrochloride
Active ingredient
Metformin Hydrochloride
Route
Oral
NDC
50090-1494
FDA application
ANDA201991
Affected lot / code info
Lot# 4260340; Exp.12/31/2025.

Why it was recalled

Presence of Foreign Tablets/Capsules.

Recalling firm

Firm
A-S Medication Solutions LLC
Manufacturer
A-S Medication Solutions
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2401 Commerce Dr, N/A, Libertyville, Illinois 60048-4464

Distribution

Quantity
411 180-count bottles
Distribution pattern
Nationwide in U.S.

Timeline

Recall initiated
2025-02-25
FDA classified
2025-03-21
Posted by FDA
2025-04-02
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0292-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: Metformin Hydrochloride · FDA Drug Recalls