# FDA recall D-1135-2019

> **USA LESS Inc.** · Class I · drug recall initiated 2019-03-05.

## Product

LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.

## Reason for recall

Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1135-2019
- **Recalling firm:** USA LESS Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-05
- **Report date:** 2019-04-17
- **Termination date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2019

## Citation

> AI Analytics. FDA recall D-1135-2019. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1135-2019. Source: US FDA. Licensed CC0.

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