90%Confidence
0Views
FDASource
2026-03-27Date
Summary
The WipesPlus branded recall manufactured by Acme United represents the fourth related recall for similar CGMP violations, indicating persistent quality control failures that could trigger more severe FDA enforcement actions. This pattern suggests Acme may face significant remediation costs and potential manufacturing suspension if issues aren't promptly addressed.
Actionable: Retailers and distributors should temporarily suspend orders of all Acme United antiseptic products until the company demonstrates corrective actions to the FDA.
AI Confidence: 90%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productWipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklah
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