Enforcement WeeklyRegister of FDA actions · supplements, cosmetics, food
Records as of 2026-09-28 · 202 actions this year · not affiliated with the FDA

Class I · Recall · initiated March 13, 2026 · Ongoing

Other Other

Pure Vitamins recalls Boner Bears and two other honey pouches for undeclared sildenafil

A Tampa firm recalled three male enhancement honey pouch products, Boner Bears, Blue Bull Extreme and Red Bull Extreme, sold in New Jersey, after FDA analysis found undeclared sildenafil and tadalafil, prescription erectile dysfunction drugs.

The record

Firm
Pure Vitamins and Natural Supplements, LLC, Tampa, FL
Products (3)
Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before Intercourse. MANUFACTURED IN: FLORIDA. UPC 788362191603Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Blue Bull Corporation Made In USA. UPC Code 707443349917Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Red Bull Corporation. Turkey www.redbullhoney.com UPC Code 9554100205595
Reason, as filed
“FDA analysis revealed the presence of undeclared sildenafil and Tadalafil”
Classification
Class I (Class I: reasonable probability of serious health consequences or death)
Recall numbers
H-0653-2026, H-0654-2026, H-0655-2026
Initiated
March 13, 2026
Posted by FDA
April 15, 2026
Status
Ongoing · Voluntary: Firm initiated
Quantity
Unknown
Distribution
New Jersey

Verify: search any recall number above in FDA's enforcement report database.

Why it happened, in plain English

The filed reason: “FDA analysis revealed the presence of undeclared sildenafil and Tadalafil.” These are the active ingredients in prescription erectile dysfunction drugs. A product sold as honey, with a “dosage” line telling the buyer to consume a pouch “30 minutes before intercourse,” that then turns out to contain those drugs is not a supplement with a labeling problem. It is an unapproved drug sold as food.

The record does not say where the products were made beyond “Florida” for one and, on the labels, “Blue Bull Corporation” and “Red Bull Corporation, Turkey” for the others. The recalling firm is the Tampa distributor. The quantity is listed as “Unknown,” which usually means the firm could not reconstruct what it sold. That is its own finding. In general terms, a distributor of imported or private-label sexual enhancement products has one real control: testing the product for drug adulterants before selling it.

Who else should care

Any distributor, online seller or convenience-store supplier that handles “male enhancement” honeys, gummies or capsules. In general terms, this is a product category where hidden drug ingredients are the main risk, and a seller who cannot show test results has no basis for claiming the product is what its label says.

Check: whether you have a lab result showing no undeclared drugs for every lot of enhancement product you sell, and whether you can state exactly how many units went out.

Written 2026-09-08. Analysis is editorial; the record above is FDA's.