PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: September 9, 2020 Initiated: June 30, 2020 #F-1449-2020

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Sundial Herbal Products
Units Affected
Unknown
Distribution
NY
Location
Bronx, NY

Frequently Asked Questions

What product was recalled?
SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag. Recalled by Sundial Herbal Products. Units affected: Unknown.
Why was this product recalled?
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Which agency issued this recall?
This recall was issued by the FDA Food on September 9, 2020. Severity: Moderate. Recall number: F-1449-2020.