NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel — Class II drug recall D-0002-2019
Terminated recall by BioLyte Laboratories, LLC, reported 2018-10-10, distributed nationwide. CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc.
| Recall number | D-0002-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioLyte Laboratories, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2018-08-31 |
| Classified | 2018-10-01 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 58368-0002, 58368-0002-02 |
| Expiration dates | 2019-10-10, 2020-01-31, 2020-03-29 |
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.
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-0002-2019. 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.