Xrect Male Enhancement Supplement Recalled for Undeclared Prescription Drugs
Organic Herbal Supply is recalling Xrect Male Enhancement capsules because FDA analysis found undeclared prescription drugs tadalafil, sildenafil, and Flibanserin.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 use of the product will cause serious adverse health consequences or death.
Plain-English summary
Organic Herbal Supply is recalling Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, in 2, 4, and 10 count packages. The product was distributed nationwide via the internet. The recall covers all lots and package sizes.
The FDA initiated this recall because the product 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 taking certain heart medications.
Consumers who have purchased this product should stop using it immediately. They should contact Organic Herbal Supply for a refund or further information. The product is identified by UPC Code 680474015795.
The recalled product
- Product
- Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795
- 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.
See all 11 products in this recall →Related recalls
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