FDA Drug recall D-1339-2014
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA
- FDA Drug
- Class I
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class I recall of ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA by Schindele Enterprises, citing marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1339-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-01-09 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Schindele Enterprises |
| Distribution | CA, CT, FL, GA, IA, IL, LA, MD, NV, NY, PA, TX, WI |
Product
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.
Reason
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Identifiers
| code_info | Lot 0512058, Exp. 05/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1339-2014%22
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