Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules - CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0. 83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Source: FDA | Recall date: 05/13/2026

Don't want to manually check every recall?

Track your baby products and get automatic recall alerts when something may affect your family.

Start Free Recall Tracking How Recall Alerts Work

Learn more about the baby product recall tracker, baby product recall alerts, or recall monitoring plans.

Affected product: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules

Summary: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0. 83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Hazard: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0. 83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Open Official Recall Notice Back to Home

Don't want to manually check every recall?

Track your baby products and get automatic recall alerts when something may affect your family.

Start Free Recall Tracking How Recall Alerts Work

Learn more about the baby product recall tracker, baby product recall alerts, or recall monitoring plans.