Esupplementsales, LLC recalls HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 3649…

Recall date

January 28, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0561-2022

FDA classification

Class I

Brand / firm

Esupplementsales, LLC

Sold / distributed

Nationwide in the USA via Amazon at www.amazon.com

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

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