A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.
The list below includes voluntary recalls in which public notification has been issued.
See FDA’s role in drug recalls for more information.
See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
For recall notices older than 60 days, see recall and safety alerts archive.
Resources for You
- Recalls, Market Withdrawals, & Safety Alerts
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Enforcement Reports
- Drug Safety Communications
- Drug Alerts and Statements
- FDA Recall Information on Twitter
- Basic Reset and Biogenyx Recalled Products
|Date||Brand Name(s)||Product Description||Recall Reason Description||Company Name||Terminated Recall|
|NS NY Distributor Inc||Premium Orgazen 7000 and Ginseng Power 5000 capsules||Undeclared Sildenafil and/or Tadalafil||NS NY Distributor Inc|
|PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500||Dietary Supplement for male sexual enhancement||Undeclared Tadalafil||Yolo Studio|
|IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000||Dietary Supplement for male sexual enhancement||Undeclared Sildenafil and/or Tadalafil||QMART|
|A-S Medication Solutions, LLC||Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana||Products contain an incomplete prescription drug label||A-S Medication Solutions, LLC|
|Thumbs Up 7, Shogun, Krazy Night||Dietary Supplement for male sexual enhancement||Undeclared Sildenafil, Tadalafil, Vardenafil||Ummzy LLC|
|Thumbs Up 7, Shogun-X, 69MODE||Dietary Supplement for male sexual enhancement||Undeclared Sildenafil, Tadalafil, Vardenafil||Nuri Trading LLC|
|Apotex Corp.||Guanfacine Extended-Release Tablets 2mg||Trace amounts of Quetiapine Fumarate||Apotex Corp.|
|Thumbs Up 7||Blue 69K Dietary Supplement for male sexual enhancement||Undeclared Sildenafil and Tadalafil||Bit & Bet LLC|
|Thumbs Up 7||Dietary Supplement for male sexual enhancement||Undeclared Sildenafil and Tadalafil||Antoto-K|
|PremierZen||Dietary Supplement for male sexual enhancement||Undeclared Sildenafil and Tadalafil||Namoo Enterprise LLC|