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  1. Drug Safety and Availability

Drug Recalls

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.

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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall
ChloraPrep ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Defective applicator Becton, Dickinson and Company
Durisan Hand sanitizer Product is contaminated with Burkholderia contaminans Sanit Technologies LLC d/b/a Durisan
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
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