US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

      Summary Company Announcement Date: July 10, 2025 FDA Publish Date: July … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Hi-Tech Pharmaceuticals Recalls All Lots of Stamina-Rx Dietary Supplement Products

Hi-Tech Pharmaceuticals Recalls All Lots of Stamina-Rx Dietary Supplement Products

June 17, 2009 By The FDA Leave a Comment

Norcross, GA – Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company’s product sold under the name Stamina-Rx.

On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA’s lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient ? benzamidenafil ? a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). FDA notified Hi-Tech that, based on certain labeling claims made by the firm, Stamina-Rx is a drug as defined in the Act. Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The labeling at issue was not on bottles of Stamina-Rx, but was contained in certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with FDA since September 23, 2003. In accordance with the Decree, FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088] or by returning the postage paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787 or fax [1-800-FDA-0178].

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

July 10, 2025 By The FDA

Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination

July 10, 2025 By The FDA

Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards

July 9, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology

July 9, 2025 By The CPSC

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 2025 By The CPSC

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

CHS Inc. Recalls Payback Champion Lamb Feed Due to Elevated Copper Health Risk

July 9, 2025 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
  • Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination
  • Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards
  • WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE
  • Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard
  • SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology
  • AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA
  • Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm
  • Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in