Drug & medication recalls High risk

Vitality recalled over undeclared sildenafil

Recall date
February 20, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
One Source Nutrition, Inc, recalls Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle…
Recall number
D-0281-2025
FDA classification
Class I
Brand / firm
One Source Nutrition, Inc,
Sold / distributed
Nationwide in the U.S.A

Why it was recalled

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

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

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

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