# FDA recall D-0388-2019

> **Happy Together, Inc.** · Class I · drug recall initiated 2019-01-08.

## Product

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

## Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

## Distribution

Product was sold over the internet

## Key facts

- **Recall number:** D-0388-2019
- **Recalling firm:** Happy Together, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-08
- **Report date:** 2019-01-30
- **Termination date:** 2021-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boynton Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2019

## Citation

> AI Analytics. FDA recall D-0388-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0388-2019. Source: US FDA. Licensed CC0.

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