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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- BioLyte Laboratories, LLC
- Category
- Drug — OTC Topical
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.
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