Duloxetine recalls

Duloxetine products have been recalled 29 times, most recently on 17 Jun 2026. The recalling company is usually Breckenridge Pharmaceutical. The most common reason is nitrosamine impurity.

Total recalls29since 2015

Last 12 months10reported

Class I00% of total

Ongoing25latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 2 0Feb 3 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 27 93%Class III 2 7%

Why duloxetine is recalled

Companies

Product types

Antidepressants29100%

By year

2026724%
20251552%
2024517%
201713%
201513%

Ongoing duloxetine recalls

25 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

29 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
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
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
23 Oct 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 20mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
26 Jun 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 20 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Dec 2017Drug	CLASS III	Duloxetine Delayed-Release Capsules USP, 30 mg recalledDuloxetine	Lupin Pharmaceuticals	Potency & Assay	Nationwide
18 Nov 2015Drug	CLASS III	Duloxetine Delayed-release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.