Changeflow GovPing Pharma & Drug Safety Class I Drug Recall D-0396-2026 - Mojo Max Fusi...
Urgent Enforcement Added Final

Class I Drug Recall D-0396-2026 - Mojo Max Fusion XXX

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Filed March 17th, 2026
Detected March 27th, 2026
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Summary

The FDA has initiated a Class I drug recall (D-0396-2026) for Mojo Max Fusion XXX capsules due to undeclared sildenafil and tadalafil. The recall, initiated voluntarily by Mohamed Hagar, affects all lots distributed nationwide.

What changed

The Food and Drug Administration (FDA) has classified a Class I recall (D-0396-2026) for 'Mojo Max Fusion XXX, 500 mg' capsules, initiated voluntarily by Mohamed Hagar. The recall is due to the presence of undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule), which poses a significant health risk. The product was distributed nationwide in the U.S. and includes all lots with an expiration date of 12/31/2027.

This recall requires immediate attention from distributors and retailers to remove the affected product from shelves. Consumers who have purchased Mojo Max Fusion XXX should discontinue use immediately and consult with a healthcare professional if they have experienced any adverse effects. The FDA classifies this as a Class I recall, indicating a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

What to do next

  1. Remove all lots of Mojo Max Fusion XXX from distribution and sale.
  2. Notify downstream distributors and retailers of the recall.
  3. Consumers should cease use and consult healthcare providers if adverse effects are experienced.

Penalties

Class I recall indicates a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Source document (simplified)

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"terms": "https://open.fda.gov/terms/",
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"last_updated": "2026-03-18",
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"results": [
{
"status": "Ongoing",
"city": "Brooklyn Ctr",
"state": "MN",
"country": "United States",
"classification": "Class I",
"openfda": {
},
"product_type": "Drugs",
"event_id": "97796",
"recalling_firm": "Mohamed Hagar",
"address_1": "4952 Highway 169 N",
"address_2": "N/A",
"postal_code": "55428-4026",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "E-Mail",
"distribution_pattern": "U.S. Nationwide",
"recall_number": "D-0396-2026",
"product_description": "Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0",
"product_quantity": "125 boxes",
"reason_for_recall": "Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).",
"recall_initiation_date": "20251008",
"center_classification_date": "20260317",
"report_date": "20260311",
"code_info": "ALL LOTS, exp 12/31/2027"
}
]
}

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 17th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0396-2026

Who this affects

Applies to
Drug manufacturers Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Labeling Product Safety
Threshold
Class I recall
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Consumer Protection

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