The Recall Desk
HighFDA (Drugs)·D-0016-2023·Announced 2022-11-02

Proton Armor hand sanitizer recalled for methanol contamination

Ultra Chem Labs Corp is recalling Proton Armor hand sanitizer nationwide due to trace amounts of methanol found in a manufacturing component. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for methanol contamination in a hand sanitizer product. Methanol is a recognized health hazard, but the contamination is limited to trace amounts and no illnesses or injuries have been reported, placing this in the High category per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ultra Chem Labs Corp is recalling Proton Armor Anti-Microbial Alcohol-Free Foaming Hand Sanitizer nationwide. The product is available in three sizes: 8 oz, 32 oz, and 1.7 fl oz (50 mL) bottles.

The recall was issued due to trace amounts of methanol found in one of the manufacturing components during the production process. The product has Current Good Manufacturing Practice (CGMP) deviations associated with its manufacturing.

The affected batch is 20087131, with product codes 3020-8 (8 oz), 3020-3 (32 oz), and 3020-5 (1.7 fl oz/50 mL). No illnesses or injuries have been reported. Consumers who have purchased this product should discontinue use and consult with the manufacturer for guidance on appropriate handling.

The recalled product

Product
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details:
Manufacturer
Ultra Chem Labs Corp
Hazard
  • methanol-contamination
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.