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

Not under an active recall. Pramoxine was recalled 5 times in the past — all now closed. Most recent: Jan 21, 2022.

Most common reason: cGMP deviation (3 of these recalls)

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

Pramoxine recalls on record

none so far in 2026; 5 on record, newest first
Class II · Moderate risk

Proctofoam HC

cGMP deficiencies

Terminated cGMP deviation Mylan Pharmaceuticals Inc NDC 0037-6822-10 D-0452-2022
Class II · Moderate risk

Proctofoam HC

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0037-6822-10 D-0529-2021