FDAFebruary 13, 2023drug

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

What to do

FDA enforcement status: Terminated

Brands named

volt candy wholesale clubvoltvolt candy

UPCs

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

CPSCWorld Bright International Limited Recalls Agio Menlo Woven Patio Swings Due to Risk of Serious Injury or Death from Fall Hazard; Sold at Costco2026-05-14
FDAKirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed with 9 pieces of Filled Heart Madeleines. Distributed by Costco Wholesale Corp. Seattle, WA. Label of recalled package is read in part: TRADITIONAL MADELEINES**...2026-04-06
FDACoco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 06803349927162026-02-03
FDACoco's Italian Market Heat-n-Eat Fettuccini Alfredo in homemade Alfredo Sauce, Net Wt. 19 oz. (510g), Keep Frozen, packaged in a microwaveable plastic container, UPC 06803349936072026-02-03
FDAKirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.2026-01-31
FDACostco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.2025-11-07
FDACostco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.2025-11-07
FDACut Fresh Fruit Mix. Contains: Cantaloupe, Honeydew, Watermelon and Red Grapes. Keep Refrigerated. Packed under the following brands and sizes: 1. Fruit Mix CHWG (MCT) 1/5 lb. UPC 7 90629-11173 6. 2. Melon Mix Bowl & Grapes "HC" 2/48 oz. Harvest Cuts UPC 7 90629-10225 3. Packed by WPS, Minneapolo...2025-09-26

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