Mojo Max Fusion XXX Recall - Undeclared Sildenafil and Tadalafil
Summary
FDA has classified Class I recall D-0396-2026 for Mojo Max Fusion XXX (500 mg capsules) distributed by Max Nutrition Inc. Analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule), with the product marketed without an approved NDA or ANDA. The recall affects all lots with expiration date 12/31/2027, totaling 125 boxes distributed nationwide.
What changed
FDA classified a Class I recall for Mojo Max Fusion XXX capsules distributed by Max Nutrition Inc. after agency analysis detected undeclared active pharmaceutical ingredients sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule). The product was marketed without required FDA approval via NDA or ANDA. All lots with expiration 12/31/2027 are affected, totaling 125 boxes distributed nationwide.
Healthcare providers and consumers should be aware this product poses serious safety risks—undeclared sildenafil and tadalafil can interact with nitrates commonly prescribed for diabetes, hypertension, and heart disease, potentially causing life-threatening hypotension. Pharmacies, healthcare providers, and retailers should cease distribution and contact Max Nutrition Inc. to report any adverse events. Patients using this product should consult their healthcare provider immediately.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Mohamed Hagar
Drug Recalls (Class I)
← All Drug Recalls (Class I) Class I D-0396-2026 · 20260311 · Ongoing · Voluntary: Firm initiated
Product
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Reason for Recall
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Affected Lot Numbers / Codes
ALL LOTS, exp 12/31/2027
Quantity
125 boxes
Firm Notification Method
Distribution
U.S. Nationwide
Initiated
20251008
FDA Classified
20260317
Named provisions
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