Walker Emulsions Hand Sanitizer Recalled for Unapproved Excipient
Walker Emulsions Inc. is recalling 1-gallon bottles of 60% hand sanitizer because it contains an unapproved excipient, DA-2I Ethanol.
What this means for you
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves an unapproved excipient rather than a known pathogen or immediate physical danger, fitting the Moderate severity criteria for minor labeling or formulation errors without reported illness.
Plain-English summary
Walker Emulsions Inc. is recalling Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution (NDC 74940-0415-1). The recall was initiated after Health Canada notified the company that DA-2I Ethanol, an excipient used in the product, is not approved for use in hand sanitizers.
The affected product is identified by Lot # 209638. The product was distributed to a sister plant site in South Carolina and one donation was made to a consignee in Oregon. The majority of the hand sanitizer was shipped to Canada, where Health Canada has already received consignee information and classified the recall.
Consumers should stop using the product and contact Walker Emulsions Inc. for further instructions.
The recalled product
- Product
- Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
- Manufacturer
- WALKER EMULSIONS INC
- Category
- Drug — Hand Sanitizer
- 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 (1)
- Lot # 209638
Distribution
Part of a larger recall action
This product is one of 2 recalled by WALKER EMULSIONS INC 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 →Related recalls
Same manufacturer · WALKER EMULSIONS INC
See all →- ModerateWalker Hand Sanitizer Recalled for Unapproved Excipient
FDA (Drugs) · 2020-07-29
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