US Drug Recall Register
Class I · High risk Terminated Initiated Jan 28, 2022 (5 years ago)

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton…

Class I — High risk. Reasonable probability of serious harm or death.

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.

What was recalled

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

Recalling firm
Esupplementsales, LLC
Origin
NV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0561-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.