Medications & Supplements/Topical Products

BioLyte Laboratories, LLC: NeoRelief Topical Gel Recalled for Potential Microbial Contamination

Agency Publication Date: October 1, 2018

Summary

BioLyte Laboratories is recalling 500 sample packs and 672 bottles of NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel. The product was manufactured using active ingredients from King Bio Inc. that were recalled due to water contamination issues during production. This contamination could compromise the quality and safety of the gel, which is used for muscle cramps and restlessness. Consumers should contact their healthcare provider and return the product to the place of purchase for a refund.

Risk

The use of products containing contaminated water can lead to serious infections, especially if the gel is applied to broken skin or used by individuals with compromised immune systems. While no specific injuries have been reported for this product, the underlying raw material recall was due to microbial water contamination.

What You Should Do

Check your medicine cabinet for NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel in 4 ml sample packs or 2.0 oz (56.7g) bottles with NDC 58368-002-02.
Verify if your product matches the affected lot numbers and expiration dates: Sample packs with Lot 1146 (Exp 3/29/20); or 2.0 oz bottles with Lot 1138 (Exp 1/31/20), Lot 1139 (Exp 1/31/20), or Lot 1160 (Exp 10/10/19).
Stop using the product immediately and contact your healthcare provider or pharmacist if you have experienced any problems that may be related to using this drug product.
Return any unused product to the place of purchase for a full refund and contact BioLyte Laboratories for further instructions.
For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel (4 ml sample packs)

Model:

NDC 58368-002-02

Lot Numbers:

1146 (Exp 3/29/20)

Date Ranges: Expiration date 3/29/20

Product: NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel (2.0 oz / 56.7g bottles)

Model:

NDC 58368-002-02

Lot Numbers:

1138 (Exp 1/31/20)

1139 (Exp 1/31/20)

1160 (Exp 10/10/19)

Date Ranges: Expiration date 1/31/20, Expiration date 10/10/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81011

Status: Resolved

Manufacturer: BioLyte Laboratories, LLC

Manufactured In: United States

Units Affected: a) 500 sample packs; b) 672 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medicine cabinet for NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel in 4 ml sample packs or 2.0 oz (56.7g) bottles with NDC 58368-002-02.

Verify if your product matches the affected lot numbers and expiration dates: Sample packs with Lot 1146 (Exp 3/29/20); or 2.0 oz bottles with Lot 1138 (Exp 1/31/20), Lot 1139 (Exp 1/31/20), or Lot 1160 (Exp 10/10/19).

Stop using the product immediately and contact your healthcare provider or pharmacist if you have experienced any problems that may be related to using this drug product.

Return any unused product to the place of purchase for a full refund and contact BioLyte Laboratories for further instructions.

For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel (4 ml sample packs)

Model:

NDC 58368-002-02

Lot Numbers:

1146 (Exp 3/29/20)

Date Ranges: Expiration date 3/29/20

Product: NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel (2.0 oz / 56.7g bottles)

Model:

NDC 58368-002-02

Lot Numbers:

1138 (Exp 1/31/20)

1139 (Exp 1/31/20)

1160 (Exp 10/10/19)

Date Ranges: Expiration date 1/31/20, Expiration date 10/10/19