Product: Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason for recall: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Recall initiated: 20240712
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated