FDA Drug recall D-1350-2022
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468…
- FDA Drug
- Class I
- terminated
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class I recall of SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468… by Ultra Supplement, citing marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1350-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-07-21 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultra Supplement |
| Distribution | US |
Product
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Reason
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Identifiers
| code_info | Lot DAP272109, Exp: 4/1/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1350-2022%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.