The Recall Desk
SevereFDA (Drugs)·D-0561-2022·Announced 2022-02-16

HARD DAWN Rise and Shine Capsules Recalled for Undisclosed Tadalafil

HARD DAWN Rise and Shine capsules (500 mg) are being recalled because they contain tadalafil, an FDA-approved drug, without proper approval or labeling. The product was sold nationwide via Amazon.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls must score no lower than 4. An unapproved drug containing an active pharmaceutical ingredient (tadalafil) without proper labeling or regulatory approval represents a serious risk of harm, as consumers are unknowingly exposed to a medication that could interact with other drugs or cause adverse effects.

Plain-English summary

HARD DAWN, Rise and Shine capsules (500 mg, packaged in 10-count blisters) are being recalled by Esupplementsales, LLC due to the presence of tadalafil. Tadalafil is an FDA-approved prescription drug that was not declared on the product label or approved through the required New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) process.

Analytical testing identified tadalafil in the product, which makes it an unapproved drug product. The affected lot is Lot 2107 with an expiration date of July 2024. Approximately 500 cartons were distributed nationwide in the USA through Amazon (www.amazon.com, UPC 680044 364926, ASIN: B077XCCL59). The product was manufactured in Malaysia.

Consumers should not use this product. Anyone who has purchased HARD DAWN Rise and Shine capsules from the affected lot should discontinue use and seek medical guidance, particularly if they have taken the product, since tadalafil may interact with other medications or cause adverse effects in certain individuals.

The recalled product

Product
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Manufacturer
Esupplementsales, LLC
Category
Drug — Unapproved Drug Product
Hazard
  • unapproved-drug
  • undisclosed-active-ingredient
  • tadalafil

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 2107
  • Exp July 2024

Distribution

Distributed nationwide across the United States.

Related recalls

Same category