thejoe Benzalkonium Chloride

Benzalkonium Chloride recalls: 21 FDA reports

Recalls involving Benzalkonium Chloride. What was wrong with each batch, and how the FDA graded the risk.

21Reports

1Class I

15Ongoing

2026-07-08Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	20
Class I	1

By year reported

Year	Reports
2013	1
2018	2
2021	2
2022	1
2026	15

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL)

D-0699-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Product: Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
Where it went: Nationwide in the USA
How much: 5,555 bottles and tubes

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long

D-0693-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Product: TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.
Where it went: Nationwide in the USA
How much: 519 - 1 oz bottles

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United

D-0366-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.
Where it went: Nationwide within the United States
How much: N/A

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dyn

D-0376-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
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.
Where it went: Nationwide within the United States
How much: N/A

First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 228

D-0361-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
Where it went: Nationwide within the United States
How much: N/A

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.

D-0359-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
Where it went: Nationwide within the United States
How much: N/A

Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corpo

D-0371-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.
Where it went: Nationwide within the United States
How much: N/A

BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601,

D-0367-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.
Where it went: Nationwide within the United States
How much: N/A

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

D-0358-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
Where it went: Nationwide within the United States
How much: 212,607,900 containers

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for

D-0369-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
Where it went: Nationwide within the United States
How much: N/A

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex C

D-0375-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
Where it went: Nationwide within the United States
How much: N/A

Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Pr

D-0365-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.
Where it went: Nationwide within the United States
How much: N/A

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC

D-0360-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1
Where it went: Nationwide within the United States
How much: N/A

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St.

D-0374-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
Where it went: Nationwide within the United States
How much: N/A

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Ma

D-0370-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: CGMP Deviations
Product: Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
Where it went: Nationwide within the United States
How much: N/A

Class I

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, pac

D-0668-2022 · Class I · reported 2022-03-30 · Terminated

Why it was recalled: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Product: REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
Where it went: Nationwide in 17 States to 45 doctors.
How much: 1119 (1 oz.) bottles/ 772 (3 oz.) tubes

Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per

D-0362-2021 · Class II · reported 2021-04-21 · Terminated

Why it was recalled: CGMP Deviations
Product: Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95
Where it went: Nationwide USA and Puerto Rico; Mexico
How much: 2,152 containers

Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml p

D-0363-2021 · Class II · reported 2021-04-21 · Terminated

Why it was recalled: CGMP Deviations
Product: Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53525 26287 8 NDC: 64009-332-72
Where it went: Nationwide USA and Puerto Rico; Mexico
How much: 1,200 cases

Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Waba

D-0274-2019 · Class II · reported 2018-11-28 · Terminated

Why it was recalled: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Product: Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41
Where it went: U.S.A. Nationwide
How much: 12,540 bottles

deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 car

D-0220-2019 · Class II · reported 2018-11-14 · Terminated

Why it was recalled: CGMP Deviations: Product was released to market prior to microbiological testing.
Product: deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
Where it went: NC
How much: 869 cases

HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC

D-140-2013 · Class II · reported 2013-02-06 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Product: HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
Where it went: Distribution nationwide
How much: 2,139 bottles

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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