HARD DAWN — Class I drug recall D-0561-2022
Terminated recall by Esupplementsales, LLC, reported 2022-02-16, distributed nationwide. Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence
| Recall number | D-0561-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Esupplementsales, LLC, Reno, NV, United States |
| Recall initiated | 2022-01-28 |
| Classified | 2022-02-15 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2022-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 500 cartons |
| Reason classes | unapproved product |
| Lot numbers | 2107 |
| Expiration dates | 2024-07-20 |
Product
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Reason for recall
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
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-0561-2022. 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.