Skip to Content

tadalafil FDA Alerts

The FDA Alert(s) below may be specifically about tadalafil or relate to a group or class of drugs which include tadalafil.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for tadalafil

FDA Alerts Consumers Not to Use Two E-Liquids Sold by HelloCig Electronic Technology

Dec 11, 2018

Audience: Consumer

The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contains the undeclared drug sildenafil.

These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally.

FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation. Therefore, FDA urges consumers to stop using these products and to contact their health care professional with any concerns associated with their use.

To date, FDA is not aware of any adverse events associated with the use of HelloCig’s products. FDA encourages health care professionals and consumers to report adverse reactions experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:

  • Completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
  • Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.

Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

Mar 8, 2017

Audience: Consumer

[Posted 03/07/2017]

ISSUE: A&H Focal Inc. is voluntarily recalling all lots marketed as dietary supplements for male sexual enhancement from January 2014 to present. These products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e.sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making these tainted dietary supplements unapproved drugs.

These undeclared active ingredients pose a threat to consumers because PDE-5 Inhibitors 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.

BACKGROUND: The products were mainly sold through Asian Markets located in NJ and NY.  See the Company Announcement for the complete list of products.

RECOMMENDATION: Consumers who have any of the products should immediately stop use of the product and properly discard.  If you have further distributed this product, please notify those individuals of this recall.

Consumers with questions regarding this recall can contact Mr. Henry Choo by calling 646-327-8522, Monday through Saturday, 9am-6pm, EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/07/2017 - Recall Notice - A&H Focal Inc.]

SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient

May 8, 2013

Audience: Consumer

ISSUE: BeaMonstar Products notified the public that it is recalling its SexVoltz, Velextra, and Amerect capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil is an FDA-Approved drug used to treat male erectile dysfunction (ED), making the products unapproved new drugs.

This undeclared active ingredient poses a threat to consumers because tadalafil 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.

SexVoltz SKU’s 626570609490, 827912089028, 626570617877, 626570615316
Velextra SKU’s 626570619475, 626570619475, 626570619475, 626570619475
Amerect SKU’s 626570619031, 626570619598

The affected ‘Maximum Strength’ SexVoltz, Velextra, and Amerect are all lots distributed and sold from January of 2012 to May 7, 2013 and contain various expiration dates.

BACKGROUND: The product is used as a sexual enhancement product and all 3 products are packaged in blister type packaging in 1 & 2 caps, and in 4 capsule and 10 capsule bottles.  SexVoltz, Velextra, and Amerect was distributed Nationwide to wholesalers, retail, and via the internet.

RECOMMENDATION: BeaMonstar Products is notifying its distributors and customers by email and telephone and is arranging for credit of all recalled products. Consumers/distributors/retailers that have Sexvoltz, Velextra or Amerect which is being recalled should return to place of purchase.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[05/07/2013 - Firm Press Release - BeaMonstar Products]
[05/07/2013 - Product Photos]

Bullet Proof: Public Notification - Undeclared Drug Ingredient

May 7, 2013

Audience: Consumer

ISSUE: FDA is advising consumers not to purchase or use “Bullet Proof,” a product promoted and sold for sexual enhancement on various websites and in some retail stores. FDA laboratory analysis confirmed that “Bullet Proof” contains tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for Erectile Dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

BACKGROUND: These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.” 

RECOMMENDATION:  Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[05/07/2013 - Public Notification - FDA]

American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient

May 2, 2013

Audience: Consumer

ISSUE: May 1, 2013 - American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

These undeclared active ingredients poses a threat to consumers because tadalafil and sildenafil 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. No Adverse events have been reported related to this recall.

BACKGROUND: Vicerex is sold in blister packs containing ten (10) capsules and Black Ant is sold in a box containing four (4) individually wrapped capsules. The product is distributed worldwide by American Lifestyle by on-line sales and retail. The products are being promoted for increasing desire and sexual performance. The products are sold without medical prescription.

RECCOMENDATION: American Lifestyle is notifying its customers by telephone and email and is arranging for return of all recalled products. Consumers who have purchased Vicerex or Black Ant capsules are urged to immediately discontinue their use and return the product to their place of purchase or directly to American Lifestyle, 640 Kreag Road, Pittsford, NY 14534. Consumers are asked to have order number or proof of purchase.

Consumers with questions regarding this recall may contact American Lifestyle at 585-586-1878 Monday through Friday 7 am to 3 pm EST.

Consumers who have purchased any of these products and have any of the mentioned medical illnesses should consult their health care providers.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

 

[05/01/2013 - Press Release - American Lifestyle]

[03/16/2011 - Public Notification - FDA]

 

Mojo Nights and Mojo Nights for Her: Recall - Undeclared Drug Ingredient

Sep 21, 2012

Audience: Consumer

ISSUE: Evol Nutrition Associates, Inc./Red Dawn (“Evol Nutrition”) notified the public of a nationwide recall of all lots of two dietary supplement products distributed by the company under the names Mojo Nights and Mojo Nights for Her to the consumer level. Testing by the FDA revealed the presence of undeclared tadalafil and sildenafil in Mojo Nights (Evol Nutrition is also recalling Mojo Nights for Her). Tadalafil and sildenafil are active ingredients of FDA-approved drugs for Erectile Dysfunction (ED), making Mojo Nights an unapproved new drug.

These undeclared active ingredients 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. 

BACKGROUND: These two products were distributed nationwide via retail stores and internet sales between July 2011 and July 2012. 

RECOMMENDATION: Consumers who have the recalled product in their possession should stop using the products immediately. Customers with stock of the recalled product should destroy it or return for a refund. Evol Nutrition is notifying its customers by certified mail.


[08/23/2012 - Press Release - Evol Nutrition Associates, Inc./Red Dawn]

Cialis (tadalafil) - Oct 18, 2007

Oct 18, 2007

Audience: Urologists, other healthcare professionals, consumers

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra, Levitra, Cialis for the treatment of erectile dysfunction, and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.

[October 18, 2007 - Cialis Information page - FDA]

More tadalafil Resources