FDA Recall D-0376-2026
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
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0376-2026- 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)
- BZK PADS
- Generic name(s)
- BENZALKONIUM CHLORIDE
- Manufacturer(s)
- Dynarex Corporation
- NDC(s)
67777-245- 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.