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

Yes — there is an active recall. 1 ongoing FDA recall mention Loperamide (4 total). Check the affected lots below.

Most common reason: Temperature excursion (2 of these recalls)

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

Loperamide recalls on record

none so far in 2026; 4 on record, newest first
Class III · Low risk

Loperamide HCL Tablets USP

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Terminated Labeling / mix-up Sun Pharmaceutical Industries, Inc. D-0391-2019