D-0500-2019 Class I Terminated
FDA drug recall D-0500-2019 was initiated by Natures Rx on Jan 25, 2019 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil The recall status is terminated (terminated Feb 6, 2023). Affected quantity: 211.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 13, 2019
- Initiation Date
- Jan 25, 2019
- Termination Date
- Feb 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211
Product description
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
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Distribution pattern
eBay sales
Code information
All lots within expiry
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0500-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026