FDA (Drugs) recall action 95714
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
The agency’s own wording, quoted from the enforcement report.
PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.
ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.
VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.
ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.