# FDA recall D-0247-2018

> **Blue Fusion Natural** · Class I · drug recall initiated 2017-11-29.

## Product

BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared  sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0247-2018
- **Recalling firm:** Blue Fusion Natural
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-29
- **Report date:** 2018-02-07
- **Termination date:** 2018-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orange, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2018

## Citation

> AI Analytics. FDA recall D-0247-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0247-2018. Source: US FDA. Licensed CC0.

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