a) Firminite 805 mg is packaged in 2 count — Class I drug recall D-326-2013
Terminated recall by InSo-Independent Contractor for West Coast Nutritionals,LTD, reported 2013-05-22, distributed nationwide. Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an F
| Recall number | D-326-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InSo-Independent Contractor for West Coast Nutritionals,LTD, Allen, TX, United States |
| Recall initiated | 2012-05-18 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2015-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BZ, CA, CW, CY, DE, DK, ES, FR, GB, GR, GT, HK, IE, IN, IQ, IT, JM, JO, JP, KR, KW, KY, LV, MT, MY, NG, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, TH, TR, TT, TW, ZA |
| Quantity | 8,000 blister |
| Reason classes | undeclared allergen, unapproved product |
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.
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-326-2013. 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.