FDA Recall D-0358-2026

ACME UNITED CORPORATION · Shelton, CT

Class II Ongoing 114 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027.

Quantity: 212,607,900 containers

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0358-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2026-01-20
Classified by FDA Center: 2026-03-02
FDA published: 2026-03-11
Recalling firm: ACME UNITED CORPORATION
Firm location: Shelton, CT

Drug identification

Brand name(s): FIRST AID ONLY BZK ANTISEPTIC
Generic name(s): BENZALKONIUM CHLORIDE
Manufacturer(s): Acme United Corporation
NDC(s): 0924-7116
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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