December 2024 FDA Recall Drug by Shoppers- Plaza
D-0207-2025 - Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

This Class I drug recall was voluntarily initiated by Shoppers- Plaza on December 16, 2024 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; fda laboratory analysis confirmed product tainted with undeclared metformin and glyburide. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0207-2025

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Initiated
12-16-2024
Reported
01-29-2025
Quantity
172 180-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95994
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SHOPPERS- PLAZA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide via internet sales
Product Description About Product Description
Full technical description of the product.
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

Batch or Lot Expiration Information

Batch# 001, exp. date 09/10/2026