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Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.


Jack Rabbit Inc. Conducts Voluntary Nationwide Recall of Lot 2510 of Jack Rabbit Dietary Supplement Due to
undeclared ingredient



FOR IMMEDIATE RELEASE - August 12, 2013 - Jack Rabbit Inc. announced today that it is conducting a voluntary nationwide recall of one lot of the company's dietary supplement product sold under the following name: Jack Rabbit. The product was found to contain Sildenafil and Tadalafil. No illnesses have been reported to the company to date in connection with this product.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA for Lot 2510 found that the product contains sildenafil and Tadalafil. Sildenafil and Tadalafil are active ingredients of FDA-approved drugs for erectile dysfunction (ED), making Jack Rabbit pack DIETARY SUPPLEMENT an unapproved drug. The active drug ingredients are not listed on the product label. The undeclared 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. Additionally, the product may cause side effects, such as headaches and flushing.

Jack Rabbit Pack is marketed as a dietary supplement for sexual enhancement. It is packaged in 4 count blister packs and distributed online and retail stores nationwide.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Consumers should return any unused product to the retail location where they were purchased or email Jack Rabbit, Inc. at JackRabbit4pack.com for a return address, Monday-Friday, 9 am to 5 pm EDT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Medwatch Adverse Event Reporting Program either online, by regular mail or by fax.

Online; www.fda.gov/medwatch/report.htm

Regular mail: use postage-paid, pre-addressed form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-fda-0178

Jack Rabbit Inc., A Florida Corporation, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. Jack Rabbit Inc. is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers.



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Photo: Product Labels

Recalled Product Photos Are Also Available on FDA's Flickr Photostream.