NUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients
The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. The FDA's own Class I classification mandates a minimum severity score of 4, because the hazard of an unapproved drug containing undeclared prescription ingredients presents significant risk to consumers.
Plain-English summary
NUX Male Enhancement capsules, manufactured by Gadget Island, Inc. and distributed by SX Power CO. (Chicago, IL), are subject to a Class I FDA recall. The product is marketed as a 1-count blister card (UPC 6 01577 51236 3) with Lot# RO 927996 and expiration date 12/25/2024.
The FDA determined that this product was marketed without required FDA approval in the form of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing by the FDA found that the capsules contain undeclared sildenafil and tadalafil, which are pharmaceutical ingredients used in FDA-approved treatments for male sexual enhancement.
The product was distributed nationwide in the United States.
Consumers who have purchased NUX Male Enhancement capsules should not use them and should consult a healthcare provider if they have any health concerns related to this product.
The recalled product
- Product
- NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
- Manufacturer
- Gadget Island, Inc
- Category
- Drug — Male Enhancement
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: RO 927996
- Exp: 12/25/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Gadget Island, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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