Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Benzalkonium recalled?

Yes — there is an active recall. 25 ongoing FDA recalls mention Benzalkonium (77 total). Check the affected lots below.

Most common reason: cGMP deviation (34 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzalkonium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Benzalkonium recalls in 2026

24 initiated in 2026, 77 in total — newest first
Class II · Moderate risk

Revitaderm Wound Care

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Ongoing cGMP deviation Blaine Labs Inc NDC 63347-120-02 D-0699-2026
Class I · High risk

Revitaderm Wound Care Gel

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Ongoing Microbial contamination Blaine Labs Inc NDC 63347-120-02 D-0692-2026
Class II · Moderate risk

Dynarex

CGMP Deviations

Ongoing cGMP deviation Acme United Corporation NDC 67777-245-04 D-0376-2026
Class II · Moderate risk

Dynarex

CGMP Deviations

Ongoing cGMP deviation Acme United Corporation NDC 67777-245-01 D-0375-2026
Class II · Moderate risk

Wipes Plus

CGMP Deviations

Ongoing cGMP deviation Acme United Corporation NDC 67151-333-01 D-0368-2026