Product: BIGnHARD Male Enhancement  Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10  count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
Reason for recall: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall initiated: 20170418
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated