D-0207-2025 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2025
- Initiation Date
- December 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172 180-count bottles
Product Description
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
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Distribution Pattern
Nationwide via internet sales
Code Information
Batch # 001, exp. date 09/10/2026