Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I · High risk Ongoing Initiated Feb 20, 2025 (2 years ago)

Vitality

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

Why it was recalled

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

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

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

Recalling firm
One Source Nutrition, Inc,
Origin
AR, United States
Initiated by
Voluntary: Firm initiated
Company announcement
Feb 20, 2025 · FDA notice with lot numbers
FDA recall number
D-0281-2025 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.

Other chemical / undeclared recalls from 2025

All chemical / undeclared recalls
Class I · High risk

SILINTAN 25/pills

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Ongoing Chemical / undeclared ANTHONY TRINH, 123Herbals LLC D-0388-2026