Vegetal Vigra Capsules Recalled for Containing Unapproved Sildenafil
The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which indicates a serious health risk requiring severity score of at least 4. Although no illnesses have been reported, the presence of an unapproved active pharmaceutical ingredient that was not reviewed by the FDA for safety represents a significant regulatory violation and potential health hazard.
Plain-English summary
Vegetal Vigra 200mg capsules in 8-count bottles are being recalled nationwide. FDA analysis found the product contains sildenafil, an active ingredient used in FDA-approved medications for male sexual enhancement. The product was marketed without an FDA-approved New Drug Application or Abbreviated New Drug Application and is therefore an unapproved drug.
An unapproved drug product raises safety concerns because the FDA has not reviewed and approved it for safety, quality, or effectiveness. Pharmaceutical ingredients in unapproved products have not undergone the FDA's review process.
Consumers who have purchased Vegetal Vigra should not use the product. Anyone who has used the product and has concerns should contact their healthcare provider. For information about the recall or to report adverse effects, contact APG SEVEN, INC or the FDA.
The recalled product
- Product
- Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
- Manufacturer
- APG SEVEN, INC
- Category
- Drug
- Hazard
- unapproved-drug
- sildenafil
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)
- All lots
- Expires: 01/31/2025
Distribution
Distributed nationwide across the United States.
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