Why it was recalled
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.
Product description
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Lot numbers, UPCs & expiration codes
Lot: 2107, Exp July 2024
Where it was sold
Nationwide in the USA via Amazon at www.amazon.com
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0561-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 28, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 500 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Esupplementsales, LLC
Original FDA data
Every field from FDA enforcement report D-0561-2022, exactly as published.
Show all FDA fields
- City
- Reno
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 89501
- Address
- 1670 Saturno Heights Dr
- Code information
- Lot: 2107, Exp July 2024
- Postal code
- 89523-3217
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0561-2022
- Classification
- Class I
- Recalling firm
- Esupplementsales, LLC
- Product quantity
- 500 cartons
- Termination date
- Aug 17, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
- Distribution pattern
- Nationwide in the USA via Amazon at www.amazon.com
- Recall initiation date
- Jan 28, 2022
- Initial firm notification
- Press Release
- Center classification date
- Feb 15, 2022