FDA Recalls BIGnHARD Male Enhancement Capsules for Undeclared Prescription Drugs
Organic Herbal Supply is recalling BIGnHARD Male Enhancement Capsules because FDA testing found undeclared prescription drugs, including tadalafil and sildenafil.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. The presence of undeclared prescription drugs in a dietary supplement is a severe hazard.
Plain-English summary
Organic Herbal Supply is recalling BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, in 2, 4, and 10-count packages. The product is made in Malaysia and distributed nationwide via the internet. The recall includes all lots and package sizes.
The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis detected the presence of undeclared tadalafil, sildenafil, and/or their analogues, as well as Flibanserin. These are prescription medications that can have serious side effects, particularly for individuals with certain medical conditions or those taking other medications.
Consumers who have purchased BIGnHARD Male Enhancement Capsules should stop using the product immediately. They should contact Organic Herbal Supply for a refund or further information. The product is identified by UPC Code 680474229086.
The recalled product
- Product
- BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
- Manufacturer
- Organic Herbal Supply
- Category
- Drug — Dietary Supplement
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 (1)
- All lots and package sizes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Organic Herbal Supply 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.
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