Medications & Supplements/Dietary Supplements

HARD DAWN Rise and Shine Capsules Recalled for Undeclared Tadalafil

Agency Publication Date: February 9, 2022

Summary

HARD DAWN Rise and Shine capsules (500 mg) are being recalled because they contain tadalafil, an FDA-approved prescription drug for erectile dysfunction that was not declared on the label. Approximately 500 cartons of the 10-count blister packs were distributed nationwide through Amazon. The recall affects lot number 2107 with an expiration date of July 2024.

Risk

Tadalafil can interact with nitrates found in some prescription drugs, which may lower blood pressure to dangerous or life-threatening levels. This pose a significant risk to people with heart disease, high blood pressure, or diabetes who often take nitrates.

What You Should Do

This recall affects HARD DAWN Rise and Shine capsules (500 mg) sold in 10-count blister packs with UPC 680044364926 and ASIN B077XCCL59.
Check the product packaging for lot number 2107 and an expiration date of July 2024 to determine if your product is included in the recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Esupplementsales, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: HARD DAWN Rise and Shine capsules (500 mg)

Variants: 10-count blisters per carton

UPC Codes:

680044364926

Lot Numbers:

2107 (Exp July 2024)

ASIN: B077XCCL59. Recall #: D-0561-2022. Manufactured in Malaysia.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89501

Status: Resolved

Manufacturer: Esupplementsales, LLC

Sold By: Amazon; www.amazon.com

Manufactured In: Malaysia

Units Affected: 500 cartons

Distributed To: Nationwide

Agency Last Updated: February 15, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects HARD DAWN Rise and Shine capsules (500 mg) sold in 10-count blister packs with UPC 680044364926 and ASIN B077XCCL59.

Check the product packaging for lot number 2107 and an expiration date of July 2024 to determine if your product is included in the recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Esupplementsales, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.