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

Yes — there is an active recall. 44 ongoing FDA recalls mention Duloxetine (63 total). Check the affected lots below.

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

Duloxetine recalls on record

none so far in 2026; 63 on record, newest first
Class II · Moderate risk

DULoxetine DR USP

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-0163-2025
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-165-30 D-0568-2024