ACME UNITED CORPORATION

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
0
Inspections
14
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0369-2026Class IIDynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", ManufacJanuary 20, 2026
D-0361-2026Class IIFirst Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United CorporJanuary 20, 2026
D-0367-2026Class IIBZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville,January 20, 2026
D-0373-2026Class IIHand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 TaJanuary 20, 2026
D-0375-2026Class IIDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured forJanuary 20, 2026
D-0366-2026Class IIMed Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: AcJanuary 20, 2026
D-0377-2026Class IIChildren's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 peJanuary 20, 2026
D-0368-2026Class IIWipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: January 20, 2026
D-0358-2026Class IIFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04January 20, 2026
D-0360-2026Class IIDukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: January 20, 2026
D-0365-2026Class IIMedi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for January 20, 2026
D-0374-2026Class IIGreen Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green GJanuary 20, 2026
D-0370-2026Class IICleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FLJanuary 20, 2026
D-0378-2026Class IIAntimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., IncJanuary 20, 2026
D-0359-2026Class IIFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.January 20, 2026
D-0371-2026Class IIMed-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme UnJanuary 20, 2026
D-0372-2026Class IIWP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products,January 20, 2026
D-0364-2026Class IISavannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise,January 20, 2026
D-0362-2026Class II1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,January 20, 2026
D-0363-2026Class IIMax Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max PackagingJanuary 20, 2026