Stop using now Drug recall · FDA · Published January 28, 2022

HARD DAWN Rise and Shine Capsules: Unapproved Drug Risk

Esupplementsales recalls HARD DAWN Rise and Shine 500mg capsules due to unapproved drug content. Analytical testing found tadalafil, a FDA-approved drug, making this product unapproved. Consumers should stop using immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0561-2022Drug Esupplementsales ›

Stop using this now

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.

Take action

Contact the company

Official pagewww.amazon.com

Recalling firmEsupplementsales, LLC1670 Saturno Heights Dr · Reno, NV 89523-3217

✎ GovInfoNow plain-language explainer

Esupplementsales is recalling HARD DAWN Rise and Shine capsules because they contain tadalafil, a drug approved by the FDA. This makes the product unapproved and potentially unsafe for use. Read more at govinfonow.com/recall/35247-hard-dawn-rise-and-shine-capsules-unapproved-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35247-hard-dawn-rise-and-shine-capsules-unapproved-drug-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0561-2022

Cite this page

“HARD DAWN Rise and Shine Capsules: Unapproved Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35247-hard-dawn-rise-and-shine-capsules-unapproved-drug-risk. Based on FDA recall #D-0561-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0561-2022%22&limit=1).

The FDA announced on Jan. 28, 2022, that Esupplementsales, LLC voluntarily recalled HARD DAWN and Rise and Shine capsules because they contained undeclared tadalafil, an unapproved drug ingredient. The firm distributed 500 cartons nationwide via Amazon.

How to tell if you have it

Brand: Esupplementsales
Product names: HARD DAWN, Rise and Shine capsules
Strength: 500 mg
Packaging: 10-count blisters per carton
Origin: Made in Malaysia
UPC: 680044 364926 (also listed as upc 00680044364926)
ASIN: B077XCCL59
Lot code: 2107
Expiration date: July 2024
Distribution: Nationwide in the USA via Amazon at www.amazon.com

The hazard

The capsules were marketed without an approved New Drug Application or Abbreviated New Drug Application. Analytical testing by Amazon revealed the presence of tadalafil, which is an FDA-approved drug but makes this specific product an unapproved drug.

Context

GovInfoNow's records show other recent recalls of similar products include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15) and Agebox iKids-Growth Day Formula Capsules (2025-10-28). Additional recent actions include the Buy-Herbal Kian Pee Wan Capsules Recall reported on 2026-03-21.

How to tell if you have this one

Check for HARD DAWN Rise and Shine capsules with 500mg strength, 10-count blister packs, made in Malaysia, UPC 680044, lot number 2107, and expiration date July 2024.

Brand
Esupplementsales
Product
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using HARD DAWN Rise and Shine capsules as they contain an unapproved drug.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA via Amazon at www.amazon.com” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Jan 28, 2022Firm started the recall
Feb 15, 2022FDA classified it Class I
Feb 16, 2022Published in FDA’s Enforcement Report
Aug 17, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Take action

Contact Esupplementsales

We’ve drafted a message you can send Esupplementsales to request your refund or repair — edit it as you like.

✉️ Open in emailCompany site

Subject: Recall D-0561-2022 — Esupplementsales HARD DAWN Rise and Shine Capsules: Unapproved Drug Risk

Hello,

I own a HARD DAWN Rise and Shine Capsules: Unapproved Drug Risk that is covered by recall D-0561-2022 from Esupplementsales.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Link to this recall

<a href="https://govinfonow.com/recall/35247-hard-dawn-rise-and-shine-capsules-unapproved-drug-risk">HARD DAWN Rise and Shine Capsules: Unapproved Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0561-2022 (January 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0561-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.