The Recall Desk
CriticalFDA (Drugs)·D-021-2014·Announced 2013-12-04

Jack Rabbit Herbal Supplement Recalled for Undeclared Prescription Ingredients

Jack Rabbit, Inc. is recalling its J.R. Jack Rabbit All Natural Herbal Supplement because FDA testing found undeclared sildenafil and tadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Jack Rabbit, Inc. is recalling 1,000 tablets of J.R. Jack Rabbit All Natural Herbal Supplement. The product is marketed as a male enhancement supplement with a lot number of 2510 and an expiration date of 04/01/15. It was distributed nationwide.

The recall was initiated because laboratory analysis conducted by the FDA determined that the product contains two undeclared active pharmaceutical ingredients: sildenafil and tadalafil. These ingredients are typically found in prescription medications for erectile dysfunction. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who purchased this product should stop using it immediately. The presence of undeclared prescription ingredients poses a risk to consumers, particularly those with heart conditions or those taking other medications that may interact with sildenafil or tadalafil.

The recalled product

Product
J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934
Manufacturer
Jack Rabbit, Inc
Affected units
1,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: 2510 Exp 04/01/15

Distribution

Distributed nationwide across the United States.