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Recall Observatory FDA recall evidence

Drug 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

D-0207-2025

December 16, 2024

Class I

Product summary

Firm
SHOPPERS- PLAZA
Event
Event 95994
Status
Ongoing
Classification
Class I
Quantity
172 180-count bottles
Official record key
drug-enforcement:D-0207-2025

Official wording

Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

Code information: Batch # 001, exp. date 09/10/2026

Distribution pattern: Nationwide via internet sales

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide