Nature's Rx Silver Bullet 10x Capsules Recalled for Undeclared Sildenafil and Tadalafil
Nature's Rx is recalling Silver Bullet 10x Capsules sold on eBay because FDA analysis found undeclared sildenafil and tadalafil.
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
Nature's Rx is recalling 211 units of the silver bullet 10x Capsules, 725 mg each, 10 count mylar package. The product is a proprietary blend containing Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, and Piperine. The recall covers all lots within expiry.
The recall was initiated because the product was marketed without an Approved NDA/ANDA. FDA analysis determined that the product is tainted with undeclared sildenafil and tadalafil. These are active pharmaceutical ingredients not listed on the product label.
The affected products were distributed via eBay sales. Consumers who purchased these capsules should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA
- Manufacturer
- Natures Rx
- Category
- Drug — Dietary Supplement
- Affected units
- 211
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 within expiry
Distribution
Distribution scope not specified by the agency.
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