Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G…
Pure Vitamins and Natural Supplements, LLC recalled this product and the FDA reported the enforcement action on 15 April 2026 as Class I. The recall was initiated by the firm. FDA analysis revealed the presence of undeclared sildenafil
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Red 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 for recall
- FDA analysis revealed the presence of undeclared sildenafil
- Recalling firm
- Pure Vitamins and Natural Supplements, LLC
- Firm location
- Tampa, Florida, United States
- Classification
- Class I
- Status
- Ongoing
- Recall number
- H-0655-2026
- Quantity
- Unknown
- Distribution
- New Jersey
- Initiated
- 13 March 2026
- Reported by FDA
- 15 April 2026
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- B/N ORB524 MFG Date: MAY 2024 EXP DATE: MAY 2029
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 3 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. All 3 of them are listed on this page.
- This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
- The FDA published the enforcement report 5 weeks after the firm began the recall.
- Most meat and poultry is regulated by USDA FSIS rather than the FDA, so a product appearing in this FDA dataset is usually a closed-faced sandwich, a product with meat as a minor ingredient, or a food FSIS does not claim.
What this recall was for
Undeclared allergens
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.135(c)(2)
- Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
- 21 CFR 101.4
- Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Filed under meat and poultry and dietary supplements. A product can sit in more than one.
Every product in this recall
The FDA opened 3 enforcement records for this one recall, one per product code. This page carries all of them; the 2 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2026-04-15 | Blue 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 707443349917 | Pure Vitamins and Natural Supplements, LLC | FDA analysis revealed the presence of undeclared sildenafil | Class I |
| 2026-04-15 | 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 788362191603 | Pure Vitamins and Natural Supplements, LLC | FDA analysis revealed the presence of undeclared sildenafil and Tadalafil | Class I |
Other meat and poultry recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Pure Vitamins and Natural Supplements, LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2026-04-15 | Blue 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 707443349917 | Pure Vitamins and Natural Supplements, LLC | FDA analysis revealed the presence of undeclared sildenafil | Class I |
| 2026-04-15 | 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 788362191603 | Pure Vitamins and Natural Supplements, LLC | FDA analysis revealed the presence of undeclared sildenafil and Tadalafil | Class I |
All 3 records for Pure Vitamins and Natural Supplements, LLC
All 2026 recalls · All FDA food recall data
21 CFR 117.135(c)(2) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.