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.
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.
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.
The capsules contain tadalafil, a drug that is approved by the FDA. However, this product was marketed without an approved NDA or ANDA, meaning it's not legally approved for sale. This could lead to health risks if used without proper medical oversight.
Anyone who owns or uses HARD DAWN Rise and Shine capsules. People most at risk are those who have taken the capsules without knowing they contain an unapproved drug.
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.
Immediately stop using HARD DAWN Rise and Shine capsules as they contain an unapproved drug.
The capsules contain tadalafil, a FDA-approved drug, but were marketed without an approved NDA or ANDA, making them unapproved.
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.
Stop using the capsules immediately as they contain an unapproved drug.
We’ve drafted a message you can send Esupplementsales to request your refund or repair — edit it as you like.
Subject: Recall D-0561-2022 — Esupplementsales Esupplementsales Hello, I own a Esupplementsales 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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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.
