CLASS II ONGOING Drug recall · Reported 22 Jun 2022 · FDA Enforcement Report
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer recalled
A.P. Nonweiler is recalling Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged, distributed in Virginia, Wisconsin. The recall was initiated on 11 May 2022 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-1142-2022
- FDA event ID
- 90298
- Recalling firm
- A.P. Nonweiler, Oshkosh, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 May 2022
- FDA classified
- 10 Jun 2022
- Reported
- 22 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 May 2022 | Recall initiated by company | |
| 10 Jun 2022 | Classified by FDA | +30 days |
| 22 Jun 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Product as listed by the FDA
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
Where it was distributed
Distributed in States of WI and VA
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Which lots are affected?
Lot: 54931, No Expiration date.
Where was it sold?
Distributed in States of WI and VA
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 Alcohol Antiseptic recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer recalled | Jarman's Midwest Cleaning Systems | Foreign Material | Nationwide |
| Drug | CLASS II | Alcohol Antiseptic Topical Solution, Ethyl Alcohol recalled | Leiper's Fork Distillery | Packaging Defects | TN |