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 |
|---|---|---|---|---|
| Jan 9, 2014 | MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Po... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manuf... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also ... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc.... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bay... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
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.