5K Premium Enhancement capsules recalled for undeclared sildenafil and tadalafil
Happy Together, Inc. is recalling 5K Premium Enhancement capsules because FDA analysis found undeclared sildenafil and tadalafil.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a score of 5 per the rubric.
Plain-English summary
Happy Together, Inc. is recalling 5K Premium Enhancement capsules, 5000 mg, 1 count blister card, box of 30. The product was sold over the internet.
The FDA is recalling this product because it was marketed without an Approved NDA/ANDA. FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil.
Consumers who have this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
- Manufacturer
- Happy Together, Inc.
- Category
- Drug — Dietary Supplement
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
Distribution scope not specified by the agency.
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