US Drug Recall Register
Class I · High risk Terminated Initiated Mar 30, 2021 (5 years ago)

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes…

Class I — High risk. Reasonable probability of serious harm or death.

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.

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

Recalling firm
Ummzy, LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0662-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.