5K Premium Enhancement capsule — Class I drug recall D-0388-2019
Terminated recall by Happy Together, Inc., reported 2019-01-30. Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and
| Recall number | D-0388-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Happy Together, Inc., Boynton Beach, FL, United States |
| Recall initiated | 2019-01-08 |
| Classified | 2019-01-22 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2021-10-26 |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00649964965644 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0388-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.