# FDA recall D-326-2013

> **InSo-Independent Contractor for West Coast Nutritionals,LTD** · Class I · drug recall initiated 2012-05-18.

## Product

a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg  is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com

## Reason for recall

Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.

## Distribution

Nationwide in the United States, U.S. Virgin Islands, Puerto Rico and to the following locations:      United Kingdom, United Arab Emirates, Turkey, Trinidad & Tobago, Thailand, Taiwan, Sweden, St. Maarten, Spain, South Africa, Singapore, Saudi Arabia, Russia,  Romania, Qatar, Portugal, Poland, Philippines, Papua New Guinea, Pakistan, Oman, Norway, Nigeria, New Zealand, Netherlands Antilles, Netherlands, Mozambique, Montenegro, Mauritius, Malta, Maldives, Malaysia, Latvia, Kuwait, South Korea, Jordan, Japan, Jamaica, Italy, Ireland, Iraq, India, Hong Kong, Guatemala, Greece, Germany, France, England, Denmark, Cyprus, Curacao, Congo, Cayman Islands, Canada, Australia, Belize, and Turks and Caicos Islands.

## Key facts

- **Recall number:** D-326-2013
- **Recalling firm:** InSo-Independent Contractor for West Coast Nutritionals,LTD
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-18
- **Report date:** 2013-05-22
- **Termination date:** 2015-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allen, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-326-2013

## Citation

> AI Analytics. FDA recall D-326-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-326-2013. Source: US FDA. Licensed CC0.

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