FDA Class II Recall for BZK PADS

FDA: Drug Recalls Class II

Filed March 11th, 2026

Detected March 23rd, 2026

Summary

The FDA has initiated a Class II recall for BZK PADS (Benzalkonium Chloride) manufactured by Dynarex Corporation, distributed by ACME UNITED CORPORATION. The recall is due to CGMP deviations and is ongoing nationwide.

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What changed

The U.S. Food and Drug Administration (FDA) has classified a recall of BZK PADS (Benzalkonium Chloride 0.13%) as Class II, indicating that use or exposure to the product may cause temporary or medically reversible adverse health consequences. The recall, initiated voluntarily by ACME UNITED CORPORATION, is due to CGMP (Current Good Manufacturing Practice) deviations identified in the manufacturing process. The affected product includes specific lots with expiration dates in June 2027.

This enforcement action requires immediate attention from any entities involved in the distribution or handling of the recalled product. Compliance officers should review their inventory for the affected lots (Lot #: 53518, 53519) and implement the recall procedures as outlined by the FDA and the recalling firm. Failure to comply with recall procedures can result in further regulatory action and potential penalties.

What to do next

Review inventory for affected BZK PADS lots (Lot #: 53518, 53519).
Implement recall procedures for affected products.
Consult FDA and recalling firm for specific return/disposal instructions.

Source document (simplified)

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