Krazy Night capsule recalled over undeclared tadalafil

Recall date

March 30, 2021

Source

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

Official notice title

Ummzy, LLC recalls Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC,…

Recall number

D-0662-2021

FDA classification

Class I

Brand / firm

Ummzy, LLC

Sold / distributed

USA Nationwide

Why it was recalled

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860