# FDA recall D-1350-2022

> **Ultra Supplement LLC** · Class I · drug recall initiated 2022-07-21.

## 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.

## Distribution

Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.

## Key facts

- **Recall number:** D-1350-2022
- **Recalling firm:** Ultra Supplement LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-21
- **Report date:** 2022-08-10
- **Termination date:** 2023-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wilmington, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2022

## Citation

> AI Analytics. FDA recall D-1350-2022. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-1350-2022. Source: US FDA. Licensed CC0.

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