Indiana Botanic Gardens Recalls Dr Blue Pain Relieving Gel Due to Blending Issues
Indiana Botanic Gardens is recalling Dr Blue Pain Relieving Gel because the product may not be uniformly blended, resulting in non-uniform distribution of the active ingredient menthol.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which is defined as unlikely to cause adverse health consequences. The issue is a manufacturing defect regarding uniform blending rather than a direct safety hazard like contamination or mislabeling of a common allergen.
Plain-English summary
Indiana Botanic Gardens, Inc. is recalling Dr Blue Pain Relieving Gel, which contains 4.6% menthol and is intended for the temporary relief of minor aches and pains of muscles and joints. The recall involves 2 oz. tubes (NDC 10578-035-05) and 5 oz. jars (NDC 10578-035-04). The specific lot affected is # 6086221, with an expiration date of 10/16.
The recall was initiated because the product may not be uniformly blended, which can result in a non-uniform distribution of the active ingredient, menthol. This is classified as a superpotent drug issue where the consistency of the active ingredient is not guaranteed across the product.
The affected products were distributed nationwide and in Puerto Rico. Consumers who have this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342
- Manufacturer
- Indiana Botanic Gardens, Inc
- Category
- Drug — Topical Analgesic
- Hazard
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 (2)
- Lot # 6086221
- Exp 10/16
Distribution
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