Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported May 22, 2013
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
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),…
InSo-Independent Contractor for West Coast Nutritionals,LTD recalled a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs … - a critical-severity action.
a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs … was recalled by InSo-Independent Contractor for West Coast Nutritionals,LTD in May 22, 2013. Reason: Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an …. Check the official notice for the remedy. Verify recall #D-326-2013 with the FDA Drug before acting.
The recall
InSo-Independent Contractor for West Coast Nutritionals,LTD issued this critical-severity FDA Drug recall-Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an ….
- Critical
- severity level
- Class I
- classification
- May 22, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-326-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-326-2013) was formally reported on May 22, 2013, with the manufacturer initiating the action on May 18, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. InSo-Independent Contractor for West Coast Nutritionals,LTD is listed as the recalling firm, operating out of Allen, TX. Federal records list the affected scope as 8,000 blister packs.
The documented reason for this recall is: 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 dr… Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,000 blister packs
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-326-2013 |
| Date reported | May 22, 2013 |
| Date initiated | May 18, 2012 |
| Recalling firm | InSo-Independent Contractor for West Coast Nutritionals,LTD |
| Firm location | Allen, TX |
| Affected scope | 8,000 blister packs |
| 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, … |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-326-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by InSo-Independent Contractor for West Coast Nutritionals,LTD. Units affected: 8,000 blister packs.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2013. Severity: Critical. Recall number: D-326-2013.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-326-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 22, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.