Class I Recall for Contaminated Hand Sanitizers

Chemical contamination has prompted a Class I recall for all lots of alcohol antiseptic 80% topical solution hand sanitizer, Soft Hands alcohol antiseptic 80% topical solution hand sanitizer, and isopropyl alcohol antiseptic 75% topical solution hand sanitizer from Jarman’s Midwest Cleaning Systems Inc, Canton, South Dakota. 

According to the June 21, 2023, US Food and Drug Administration (FDA) Enforcement Report, FDA testing revealed the presence of methanol in the products. The Class I designation is the FDA’s most serious drug recall classification and warns use of the affected product could cause serious adverse health consequences or death.

“Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death,” stated an announcement from Jarman’s Midwest Cleaning Systems dated April 3, 2023. “Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.”

The recall affects the following products, which were distributed throughout the United States:

• alcohol antiseptic 80% topical solution hand sanitizer, nonsterile solution, 3.785 L, plastic gallon bottle (no NDC), all batches manufactured/distributed by Midwest Cleaning Solutions, Canton, South Dakota, and labelled with date of manufacture (DOM) 3/26/20, 4/1/20, 4/2/20, 4/27/20, 5/4/20, 5/13/20, and 8/4/20;
• Soft Hands alcohol antiseptic 80% topical solution hand sanitizer, nonsterile solution, 1 gallon/128 fl oz/3785.41 mL, plastic gallon bottle (NDC 77518-200-01), all batches manufactured/distributed by Clean Pro Supply, Rochester, New York, and labelled with DOM 3/26/20, 4/1/20, 4/2/20, 4/4/20, 4/27/20, 5/4/20, 5/7/20, 5/13/20, 8/4/20; and
• isopropyl alcohol antiseptic 75% topical solution hand sanitizer, nonsterile solution, 3.785 L, plastic gallon bottle (NDC 74663-002-01), all batches manufactured/distributed by Midwest Cleaning Solutions and labelled with DOM 3/24/20 and 12/12/20.

All three hand sanitizer products are marketed to help decrease bacteria on the skin when soap and water are not available. They are sold in 1-gallon bottles or in cases of four 1-gallon bottles. 

Jarman’s Midwest Cleaning Systems voluntarily initiated the recall March 27, 2023. The FDA designated the recall Class I on June 14, 2023.