FDA Drug recall D-0561-2022
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
- FDA Drug
- Class I
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class I recall of HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59 by Esupplementsales, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0561-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-01-28 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Esupplementsales |
| Distribution | US |
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
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.
Identifiers
| upc | 680044364926 |
|---|---|
| code_info | Lot: 2107, Exp July 2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0561-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.