Duloxetine recalls

The FDA has published 57 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 recalls57since 2014

Last 12 months10reported

Class I00% of total

Ongoing40latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 6 11 1Feb 4 3 0May 0 1 2Aug 1 0 1Nov 2 0 0Feb 0 0 4May 3 0 0Aug 0 0

Severity split

Class I 0 0%Class II 51 89%Class III 6 11%

Why duloxetine is recalled

Companies

By year

2026712%
20252646%
20241221%
201724%
201659%
201512%
201447%

Ongoing duloxetine recalls

40 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

57 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
17 Sep 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	AZ, IN, NJ
20 Aug 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	AZ, IN, NJ
13 Aug 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
16 Jul 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 40mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
30 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 30 mg, a.) bottles recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
30 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
9 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
26 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide
19 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
19 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
19 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 20mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
5 Feb 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 20 mg recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP 20 mg recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide
15 Jan 2025Drug	CLASS II	Duloxetine DR Capsules USP 60 mg, a) recalled by Rising Pharma Holding	Rising Pharma Holding	Nitrosamine Impurity	Nationwide
15 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP 30 mg, a) recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalled	Amerisource Health Services	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Nitrosamine Impurity	FL, MS, WI
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60 mg recalled	Amerisource Health Services	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled	RemedyRepack	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.