J — Class I drug recall D-021-2014
Terminated recall by Jack Rabbit, Inc, reported 2013-12-04, distributed nationwide. Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack
| Recall number | D-021-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jack Rabbit, Inc, Melbourne, FL, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-11-27 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,000 tablets |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 2510 |
| Expiration dates | 2015-04-01 |
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
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-021-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.