FDA Drug Recalls

Recalls / Class II

Class IID-0358-2026

Product

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04

Brand name
First Aid Only Bzk Antiseptic
Generic name
Benzalkonium Chloride
Active ingredient
Benzalkonium Chloride
Route
Topical
NDC
0924-7116
FDA application
M003
Affected lot / code info
Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027.

Why it was recalled

CGMP Deviations

Recalling firm

Firm
ACME UNITED CORPORATION
Manufacturer
Acme United Corporation
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Waterview Dr Ste 200, N/A, Shelton, Connecticut 06484-4368

Distribution

Quantity
212,607,900 containers
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2026-01-20
FDA classified
2026-03-02
Posted by FDA
2026-03-11
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0358-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.