US Drug Recall Register
Class I · High risk Ongoing Initiated Oct 16, 2023 (3 years ago)

THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card…

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

Why it was recalled

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

What was recalled

THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7

Recalling firm
Noah's Wholesale LLC
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0158-2024

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.