5K Premium Enhancement capsule recalled over undeclared sildenafil
- Recall date
- January 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Happy Together, Inc. recalls 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 64996496…
- Recall number
- D-0388-2019
- FDA classification
- Class I
- Brand / firm
- Happy Together, Inc.
- Sold / distributed
- Product was sold over the internet
Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Get recall alerts
Free email alert whenever Happy Together, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Happy Together, Inc.