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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 101–120 of 1,000 recalls

ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

Class IOngoing

SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01

Par Sterile Products LLC

Presence of Particulate Matter.

March 4, 2024 · DrugView details →

Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

Eugia US LLC

Presence of Particulate Matter

February 15, 2024 · DrugView details →

Class ITerminated

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

FA Online Inc

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.

February 12, 2024 · DrugView details →

Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com

Today The World

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

February 6, 2024 · DrugView details →

SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683

Today The World

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

February 6, 2024 · DrugView details →

Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada

Today The World

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

February 6, 2024 · DrugView details →

Class ITerminated

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

Super Chill Products

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

February 5, 2024 · DrugView details →

Class ICompleted

TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Chemical Contamination; presence of benzene.

February 1, 2024 · DrugView details →

RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

Integrity Products

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

February 1, 2024 · DrugView details →

To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

Integrity Products

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

February 1, 2024 · DrugView details →

Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

Neptune Resources, LLC

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

January 12, 2024 · DrugView details →

Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

Neptune Resources, LLC

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

January 12, 2024 · DrugView details →

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

Neptune Resources, LLC

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

January 12, 2024 · DrugView details →

Class ITerminated

Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03

Azurity Pharmaceuticals, Inc.

Labeling: Label Mix-up

January 4, 2024 · DrugView details →

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