Duloxetine recalls

The FDA has published 55 recalls involving Duloxetine since 2014. The latest was reported on 17 Jun 2026. Most were for nitrosamine impurity. Breckenridge Pharmaceutical has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls55since 2014

Last 12 months10reported

Class I00% of total

Ongoing39latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 5 9Jan '25 1 4 3Apr 0 0 1Jul 2 1 0Oct 1 2 0Jan '26 0 0 0Apr 4 3 0Jul 0 0

Severity split

Class I 0 0%Class II 49 89%Class III 6 11%

Why duloxetine is recalled

Companies

By year

2026713%
20252444%
20241222%
201812%
201724%
201659%
201512%
201435%

Ongoing duloxetine recalls

39 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Jun 2026Drug	CLASS II	Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine	Asclemed USA	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 20 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide

All duloxetine recalls, newest first

55 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Jun 2026Drug	CLASS II	Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine	Asclemed USA	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 20 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 30 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
5 Nov 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) bottle recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide

Should you stop taking Duloxetine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.