The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0232-2018·Announced 2018-01-31

Odan Laboratories Recalls Dry to Normal Skin Starter Kit for Stability Failure

Odan Laboratories is recalling 179 kits of Dry to Normal Skin Starter Kit because the product failed stability specifications at 12 months.

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 involves a temporary or medically reversible adverse health consequence. The specific defect is a stability failure, which is a quality control issue rather than a direct contamination or acute hazard like a high-risk pathogen or structural defect.

Plain-English summary

Odan Laboratories Ltd is recalling 179 units of the Dry to Normal Skin Starter Kit (Trousse debutante pour peau seche a normale). The kit includes a Vegetable Cleanser, Night Cream, Day Cream SPF15, and Eye Cream. The product was distributed nationwide in the USA.

The recall was initiated because the product failed stability specifications, specifically showing a stability failure at 12 months under long-term room temperature conditions. The affected lots are # J203, J204 (EXP 02-2018) and # J228, J274 (EXP 09-2018). The product was manufactured in Canada by Kamins Dermatologics Inc. and distributed by Kamins Dermatologics (USA) Inc.

Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in…
Manufacturer
Odan Laboratories Ltd
Category
Drug — Topical Dermatology
Hazard
Affected units
179

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 (6)

  • Lots # J203
  • J204
  • EXP 02-2018
  • J228
  • J274
  • EXP 09-2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Odan Laboratories Ltd 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.

See all 2 products in this recall →

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