FDA recalls Dream Cream topical product due to manufacturing quality violations
Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. Manufacturing quality control deviations without reported illnesses constitute a theoretical risk-of-harm product situation, warranting High severity.
Plain-English summary
Little Moon Essentials LLC is voluntarily recalling Dream Cream, a topical skincare cream, due to manufacturing quality control deviations. The product contains camphor 0.45% and menthol 5%. The recall covers 1,264 glass jars distributed nationwide in the USA and Ontario, Canada.
The product is available in two sizes: 2-ounce (57g) glass jars with UPC 673673882145 and 4-ounce (113g) glass jars with UPC 673673888048. Affected lot codes include 328260, 321221, 425120, 427230, 327150, 326260, 320270, 321301, and 422020.
Consumers who have purchased this product should stop using it immediately and either discard the product or contact their retailer for further guidance. No illnesses or injuries have been reported in connection with this recall. The firm initiated the voluntary recall on June 20, 2024.
The recalled product
- Product
- Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
- Manufacturer
- Little Moon Essentials LLC
- Category
- Drug — Topical Skincare
- Affected units
- 1,264
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 dates on product: a) 328260
- 321221
- 425120
- 427230
- b) 327150
- 326260
- 320270
- 321301
- 422020
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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