Horny Goat Weed Capsules Recalled for Undeclared Sildenafil
To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies. Although no illnesses or injuries have been reported, undeclared sildenafil presents serious potential for drug interactions and cardiovascular effects, particularly in consumers taking other medications.
Plain-English summary
Integrity Products is recalling To the Moon Capsules (Horny Goat Weed, 1000 mg) because the product contains undeclared sildenafil, a prescription drug ingredient. The product was marketed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The affected product with lot HGW221116 (Batch 022123-1, expiration date 5/31/2025) was distributed nationwide across the United States, affecting 2,500 boxes.
Consumers who have purchased this product should stop using it immediately. Sildenafil is a prescription medication with potential for serious drug interactions and cardiovascular effects. For more information, consumers can contact Integrity Products at 1710 Fenpark Dr., Fenton, MO 63026.
The recalled product
- Product
- 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
- Manufacturer
- Integrity Products
- Category
- Drug — Dietary Supplement
- Affected units
- 2,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot HGW221116 (Batch 022123-1)
- Exp 5/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Integrity Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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