The Recall Desk
ModerateFDA (Drugs)·D-0002-2019·Announced 2018-10-10

BioLyte Recalls NeoRelief Topical Gel Due to Ingredient Contamination

BioLyte Laboratories is recalling NeoRelief topical gel because it contains active ingredients that were previously recalled for water contamination.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text notes potential quality issues due to water contamination in ingredients but does not report specific illnesses or injuries, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

BioLyte Laboratories, LLC is recalling NeoRelief for Muscle Cramping and Restlessness Homeopathic Topical Gel. The recall involves 500 sample packs (4 ml) and 672 bottles (2.0 oz / 56.7g). The product was distributed nationwide in the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The finished product was produced using active ingredients that had been recalled by the manufacturer, King Bio Inc., due to water contamination issues. This contamination could potentially affect the quality of the NeoRelief product.

Consumers should stop using the recalled product and contact BioLyte Laboratories for further instructions or a refund. The affected lot numbers are 1146 (Exp 3/29/20), 1138 and 1139 (Exp 1/31/20), and 1160 (Exp 10/10/19).

The recalled product

Product
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS)
Brand
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Lot #: a) 1146
  • Exp 3/29/20
  • b) 1138
  • 1139
  • Exp 1/31/20
  • and 1160
  • Exp 10/10/19

Distribution

Distributed nationwide across the United States.