Drug & medication recalls High risk

To the Moon Capsules recalled over undeclared sildenafil

Recall date
February 1, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Integrity Products recalls To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: I…
Recall number
D-0586-2024
FDA classification
Class I
Brand / firm
Integrity Products
Sold / distributed
Nationwide in the USA

Why it was recalled

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

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

To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

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