ALPHA MALE+ Male Enhancer Fruit Chew Strips Recalled for Unapproved Drug
ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the severity rubric, FDA Class I recalls receive a minimum score of 4, regardless of whether illnesses have been reported. The presence of an unapproved pharmaceutical ingredient in a marketed product represents a serious regulatory violation with potential health implications.
Plain-English summary
ALPHA MALE+ Male Enhancer fruit chew strips, manufactured by Alpha-Tek LLC and distributed by Umbrella Labs and Alpha Male Plus, are being recalled nationwide.
The FDA determined that the product contains tadalafil, a pharmaceutical ingredient, but was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the product was sold without the required regulatory authorization.
Consumers who have purchased this product should stop using it. All lots within expiry are affected. Anyone with questions or concerns should consult a healthcare provider.
The recalled product
- Product
- ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
- Manufacturer
- Alpha-Tek LLC
- Hazard
- unapproved-drug
- tadalafil-undisclosed
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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