CLASS II Drug recall · Reported 29 Jul 2020 · FDA Enforcement Report
Walker Hand Sanitizer, Non-Sterile Solution recalled by Walker Emulsions
Walker Emulsions is recalling Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% and, Topical, distributed in Oregon, South Carolina. The recall was initiated on 3 Jun 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1417-2020
- FDA event ID
- 85955
- Recalling firm
- Walker Emulsions, Portland, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2020
- FDA classified
- 28 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Creams, Ointments & Gels
Timeline
| 3 Jun 2020 | Recall initiated by company | |
| 28 Jul 2020 | Classified by FDA | +55 days |
| 29 Jul 2020 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Product as listed by the FDA
Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
Where it was distributed
US Distribution: Product distributed to sister plant site located in SC, and one donation made to consignee located in OR. Majority of hand sanitizer shipped to Canada (Health Canada has already received consignee information and classified the recall).
Questions about this recall
Why was it recalled?
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Which lots are affected?
Lot # 210061
Where was it sold?
US Distribution: Product distributed to sister plant site located in SC, and one donation made to consignee located in OR. Majority of hand sanitizer shipped to Canada (Health Canada has already received consignee information and classified the recall).
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85955This product is part of a recall event; the main page for the event is Hand Sanitizer (60%), Non-Sterile Solution recalled by Walker Emulsions.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hand Sanitizer (60%), Non-Sterile Solution recalled by Walker Emulsions | Walker Emulsions | Labeling Errors | OR, SC |
More recalls from Walker Emulsions
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizer (60%), Non-Sterile Solution recalled by Walker Emulsions | Walker Emulsions | Labeling Errors | OR, SC |