Potency Concerns Prompt Hand Sanitizer Recall

Omega & Delta Co. Inc. is recalling almost a dozen lots of DOP hand sanitizer. The reason for the recall, according to the November 22, 2023, US Food and Drug Administration (FDA) Enforcement Report, is “subpotent and superpotent product: During an impact assessment of the DOP hand sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.”

The recall affects 48,145 bottles of DOP Instant hand sanitizer (ethyl alcohol 65%) with moisturizers, original, 4 fluid ounces (118 mL; UPC 7 42699 00027 4), from lots 1327034, 1328034, 1277029, 1278029, 1202015, 1203015, 0246097, 0247097, 0247099, 0248099, and 0252099. The recalled sanitizer was distributed in Puerto Rico.

Omega & Delta Co. Inc. voluntarily initiated the recall on October 20, 2023. On November 14, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.