Sundial Herbal Products product recalled over labeling errors

Recall date

June 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sundial Herbal Products recalls SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTI…

Recall number

F-1449-2020

FDA classification

Class II

Brand / firm

Sundial Herbal Products

Sold / distributed

NY

Why it was recalled

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag