# FDA recall D-0002-2019

> **BioLyte Laboratories, LLC** · Class II · drug recall initiated 2018-08-31.

## Product

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02

## Reason for recall

CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0002-2019
- **Recalling firm:** BioLyte Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-31
- **Report date:** 2018-10-10
- **Termination date:** 2020-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2019

## Citation

> AI Analytics. FDA recall D-0002-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0002-2019. Source: US FDA. Licensed CC0.

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