SUSTANGO — Class I drug recall D-1350-2022
Terminated recall by Ultra Supplement LLC, reported 2022-08-10, distributed nationwide. Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
| Recall number | D-1350-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultra Supplement LLC, Wilmington, DE, United States |
| Recall initiated | 2022-07-21 |
| Classified | 2022-08-17 |
| Reported by FDA | 2022-08-10 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 750 cartons |
| Reason classes | unapproved product |
| Lot numbers | DAP272109 |
| Expiration dates | 2026-04-01 |
Product
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Reason for recall
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
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-1350-2022. 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.