FDA Drug recall D-326-2013
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…
- FDA Drug
- Class I
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class I recall of 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… by Inso Independent Contractor For West Coast Nutritionals, citing 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),….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-326-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-18 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Inso Independent Contractor For West Coast Nutritionals |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots |
|---|
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-326-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.