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

Yes — there is an active recall. 28 ongoing FDA recalls mention Octocrylene (39 total). Check the affected lots below.

Most common reason: cGMP deviation (20 of these recalls)

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

Octocrylene recalls in 2026

4 initiated in 2026, 39 in total — newest first
Class II · Moderate risk

Aloe Gator

Out of Specification for active ingredient

Ongoing Failed specification ARG Laboratories, Inc. D-0530-2024
Class II · Moderate risk

Aloe Gator

Out of Specification for active ingredient

Ongoing Failed specification ARG Laboratories, Inc. D-0523-2024