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.
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 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
Other drug recalls
- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighAlcohol Antiseptic Hand Sanitizer Recalled for Chemical Contamination
FDA (Drugs) · 2022-06-22
- SevereHand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination
FDA (Drugs) · 2022-03-30
- HighHand Sanitizer Recalled for Excess Chemical Impurities in Manufacturing
FDA (Drugs) · 2023-01-04
- ModerateHAND-I-SAN Hand Sanitizer Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2024-08-28
- HighHand Sanitizer Recalled for Impurities Exceeding Allowable Limits
FDA (Drugs) · 2023-07-19
- ModerateRock Town Distillery Hand Sanitizer Recall Due to Chemical Contamination
FDA (Drugs) · 2022-03-30