Changeflow GovPing Government General Mojo Max Fusion XXX Recall - Undeclared Sildena...
Urgent Enforcement Amended Final

Mojo Max Fusion XXX Recall - Undeclared Sildenafil and Tadalafil

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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.

Published by FDA on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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, 2026

GovPing 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

E-Mail

Distribution

U.S. Nationwide

Initiated

20251008

FDA Classified

20260317

Sources: openFDA · Raw JSON

Named provisions

Drug Recall Classification Unapproved Drug Marketing

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Last updated

Classification

Agency
FDA
Filed
October 8th, 2025
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0396-2026

Who this affects

Applies to
Pharmaceutical companies Healthcare providers Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug recall response Product safety alert Adverse event reporting
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Consumer Protection

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