Antidepressants recalls

The FDA has published 216 recalls involving antidepressants since 2012. The latest was reported on 7 Oct 2026. Most were for potency & assay. 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 recalls216since 2012

Last 12 months18reported

Class I52% of total

Ongoing58latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 6 12 1Feb 4 4 0May 2 1 4Aug 1 1 1Nov 3 1 1Feb 0 0 4May 3 1 0Aug 2 1

Severity split

Class I 5 2%Class II 158 73%Class III 53 25%

Why antidepressants is recalled

Companies

Brands

By year

2026136%
20253416%
2024199%
2023115%
202221%
202142%
202031%
201942%
201894%
2017188%

Ongoing antidepressants recalls

58 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride	Apotex	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride	Teva Pharmaceuticals USA	Other	Nationwide
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
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

All antidepressants recalls, newest first

216 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride	Apotex	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride	Teva Pharmaceuticals USA	Other	Nationwide
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
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
11 Feb 2026Drug	CLASS II	Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride	Granules Pharmaceuticals	Other	Nationwide
7 Jan 2026Drug	CLASS III	traZODONE Hydrochloride Tablets, USP, 100mg recalledTrazodone Hydrochloride	Zydus Pharmaceuticals	Other	Nationwide
17 Dec 2025Drug	CLASS II	Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride	Lupin Pharmaceuticals	Packaging Defects	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
29 Oct 2025Drug	CLASS II	Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride	Graviti Pharmaceuticals Private	Other	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 D/R, 30 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
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
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine	Torrent Pharma	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
16 Apr 2025Drug	CLASS II	Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine	Zydus Pharmaceuticals	Foreign Material	Nationwide
9 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide

Should you stop taking Antidepressants?

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.