US Drug Recall Register
Class I · High risk Terminated Initiated Sep 15, 2017 (9 years ago)

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed…

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

Why it was recalled

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

What was recalled

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056

Recalling firm
Gadget Island, Inc
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0105-2018

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.