Alcohol Prep Pads Under FDA Class II Recall Due to cGMP Deviations

The US Food and Drug Administration (FDA) has issued a Class II recall for Quick Touch Alcohol Prep Pads (70% Isopropyl Alcohol), packaged as 100 sterile pads per carton, manufactured by Yangzhou Yulou Paper Products Co., Ltd. and distributed by AUM Pharmaceuticals, based in Hauppauge, New York. The recall applies to 500 cases from Lot #20240610, with an expiration date of June 2029. The recall was voluntarily initiated on July 21, 2025, due to current Good Manufacturing Practice (cGMP) deviations, which may compromise the safety, quality, or effectiveness of the product.

The FDA classified this recall as Class II on September 23, 2025, which indicates that use of the product may cause temporary or medically reversible adverse health consequences, but the likelihood of serious injury is low. Although the specific nature of the cGMP violations has not been detailed, such deviations typically involve lapses in manufacturing controls, sanitation, equipment maintenance, or quality assurance. No adverse events or contamination have been reported to date, but the affected products were distributed nationwide. 

Quick Touch Alcohol Prep Pads are intended for topical antiseptic use, commonly used in pre-injection skin cleansing and minor wound disinfection. They are a staple in both retail and clinical pharmacy environments, often relied upon for sterile preparation procedures. Pharmacists should check for Lot #20240610, remove any affected inventory from circulation, and notify clinical staff to ensure replacement with compliant products. 

Reference
FDA. Enforcement Report. October 1, 2025. Accessed October 1, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=215036