FDA Recalls XtraHRD Male Enhancement Capsules for Unapproved Drug Ingredient
Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules because they contain N-desmethyl tadalafil, an unapproved drug ingredient.
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 mandates a severity score of 5 according to the rubric.
Plain-English summary
Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules, a herbal dietary supplement. The product is available in 500 mg capsules in 2, 4, and 10 count boxes. The recall involves approximately 100,000 to 150,000 capsules.
The FDA is recalling the product because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules contain N-desmethyl tadalafil, an analogue to tadalafil, which is an active pharmaceutical ingredient in FDA-approved drugs used to treat erectile dysfunction.
The product was distributed nationwide through Amazon.com, the firm's website www.xtrahrd.com, and www.Zrect.com. The recall covers all lots. Consumers should stop using the product and return it to the place of purchase or contact the distributor for instructions.
The recalled product
- Product
- XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
- 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
Distribution
Distributed nationwide across the United States.
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