CLASS II Drug recall · Reported 15 Sep 2021 · FDA Enforcement Report
Hand Sanitizer (alcohol 80%) recalled by Charles Paint Research
Charles Paint Research is recalling Hand Sanitizer (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer, distributed in Michigan. The recall was initiated on 2 Sep 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-0791-2021
- FDA event ID
- 88552
- Recalling firm
- Charles Paint Research, Kansas City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Sep 2020
- FDA classified
- 8 Sep 2021
- Reported
- 15 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Sep 2020 | Recall initiated by company | |
| 8 Sep 2021 | Classified by FDA | +371 days |
| 15 Sep 2021 | Published in enforcement report | +7 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: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Product as listed by the FDA
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
Where it was distributed
Distributed in Michigan
Questions about this recall
Why was it recalled?
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Which lots are affected?
Lot# 20-151 to 20-159 and 20-161 to20-163, Exp 06/11/2022
Where was it sold?
Distributed in Michigan
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 88552This product is part of a recall event; the main page for the event is Hand Sanitizer (alcohol 80%) recalled by Charles Paint Research.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hand Sanitizer (alcohol 80%) recalled by Charles Paint Research | Charles Paint Research | Manufacturing (CGMP) Deviations | MI |
More recalls from Charles Paint Research
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizer (alcohol 80%) recalled by Charles Paint Research | Charles Paint Research | Manufacturing (CGMP) Deviations | MI |
Other Hand Sanitizer (alcohol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizer (alcohol 80%) recalled by Charles Paint Research | Charles Paint Research | Manufacturing (CGMP) Deviations | MI |