Recall archive / FDA drug enforcement
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 36... — FDA record D-0561-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- Esupplementsales, LLC
- Quantity
- 500 cartons
- Agency-reported status
- Terminated
- Source record identifier
- D-0561-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 2107, Exp July 2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA via Amazon at www.amazon.com
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 16, 2022
- Recall initiation date
- Jan 28, 2022
- Center classification date
- Feb 15, 2022
- Termination date
- Aug 17, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.