Drug Recall: Little Moon Essentials Aching Head Rub for Manufacturing Defects
Little Moon Essentials Aching Head Rub is being recalled by the manufacturer for manufacturing deviations. The voluntary recall affects 6,312 units distributed nationwide and in Ontario, 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: FDA Class II voluntary recall for manufacturing practice deviations with no reported illnesses, injuries, or specific identified hazards. The manufacturing compliance issues are not detailed, making the risk theoretical.
Plain-English summary
The product being recalled is Little Moon Essentials Aching Head Rub, an over-the-counter topical product containing Camphor 3.09% and Menthol 2.55%. The recall affects two packaging types: 0.5 ounce metal tins and 1 ounce glass jars, totaling 6,312 affected units.
The recall was initiated by the manufacturer for Current Good Manufacturing Practice (CGMP) deviations. The specific manufacturing deviations are not detailed in the recall notice.
The affected products were distributed nationwide in the United States and Ontario, Canada through 2 retailers. Consumers should check the product lot codes against the official recall list to determine if their products are affected.
Consumers with affected products should stop using them immediately and contact Little Moon Essentials LLC or their retailer for information about returns or refunds.
The recalled product
- Product
- Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
- Manufacturer
- Little Moon Essentials LLC
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 6,312
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 (16)
- lot code No expiration date on product: a) 326070
- 420140
- b) 322030
- 321230
- 329230
- 321240
- 329170
- 328280
- 326090
- 322290
- 327021
- 323121
- 327221
- 429210
- 424130
- 427050
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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