FDA Recalls Little Moon Essentials Vital Vapor Balm Due to Manufacturing Deviations
Little Moon Essentials has voluntarily recalled Vital Vapor Balm (camphor 0.6%, menthol 5.2%) due to Current Good Manufacturing Practice deviations. The Class II recall affects 1,041 units distributed nationwide in the United States and Canada.
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: This is a voluntary, firm-initiated Class II recall due to manufacturing practice deviations. No illnesses, injuries, or deaths have been reported. As a precautionary voluntary recall without reported health consequences, it meets the criteria for a Moderate severity rating.
Plain-English summary
Little Moon Essentials has initiated a voluntary recall of Vital Vapor Balm due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The product is available in three package sizes: 0.5 ounce metal tins, 2 ounce glass jars, and 4 ounce glass jars. Each product contains 0.6% camphor and 5.2% menthol.
The FDA has classified this as a Class II recall affecting 1,041 units. The manufacturer initiated the recall in response to identified manufacturing process deviations during quality review.
The affected product was distributed nationwide in the United States and in Ontario, Canada, through two retailers. Affected lot codes vary by package size: lot 324280 for 0.5 ounce tins; lots 328230, 321170, 321290, 326021, 420220, and 422140 for 2 ounce jars; and lots 326040 and 328170 for 4 ounce jars. Consumers who have purchased this product should not use it.
The recalled product
- Product
- Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC…
- Manufacturer
- Little Moon Essentials LLC
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 1,041
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 (9)
- lot code no expiration date on product: a) 324280
- b) 328230
- 321170
- 321290
- 326021
- 420220
- 422140
- c) 326040
- 328170
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Little Moon Essentials LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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