Browse Drug Recalls
7 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 7 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 7 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2023 | NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power C... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 26, 2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by B... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 26, 2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packet... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distribute... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, ... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana See... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.