FDA Issues Class II Recall for Gel Hand Sanitizer Due to Subpotency

The US Food and Drug Administration (FDA) has announced a Class II recall for Spectrum Advanced Gel Hand Sanitizer (70% Ethyl Alcohol, 8 FL OZ) after testing revealed that the product was subpotent and exhibited a cloudy appearance, suggesting compromised formulation quality. The recall affects 125 040 bottles from Lot 0644682 (exp. 11/14/2026) and Lot 0644683 (exp. 11/16/2026). The sanitizer was manufactured for Medline Industries, Inc. and distributed nationwide in the US by Consumer Product Partners, LLC. The recall was voluntarily initiated on May 23, 2025, and is currently ongoing.

The FDA officially classified the recall as Class II on June 5, 2025, indicating that use of the product may cause temporary or medically reversible health effects, with the risk of serious harm considered low. The recall was prompted by concerns that the alcohol concentration was below the labeled 70% threshold, potentially reducing its effectiveness in killing bacteria and viruses. The recalling firm, Consumer Product Partners, LLC, notified customers by letter, though no public press release has been issued at this time.

Spectrum Advanced Gel Hand Sanitizer is intended as an over-the-counter antiseptic to reduce bacteria on the hands when soap and water are not available. Subpotent sanitizer may fail to effectively disinfect, posing a concern in clinical settings where hand hygiene is critical to infection prevention.