Fluoxetine recalls

Fluoxetine products have been recalled 7 times, most recently on 11 Jun 2025. The recalling company is usually Teva Pharmaceuticals U. The most common reason is nitrosamine impurity.

Total recalls7since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 11 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 2 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why fluoxetine is recalled

Companies

Product types

Antidepressants7100%

By year

2025229%
2015229%
2014343%

All fluoxetine recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
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
6 May 2015Drug	CLASS II	Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals U	Potency & Assay	Nationwide
6 May 2015Drug	CLASS II	Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals U	Potency & Assay	Nationwide
7 May 2014Drug	CLASS II	Fluoxetine Capsules, USP, 20 mg recalled by Legacy PharmaceuticalFluoxetine	Legacy Pharmaceutical Packaging	Packaging Defects	Nationwide
7 May 2014Drug	CLASS II	Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals U	Other	Nationwide
7 May 2014Drug	CLASS II	Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals U	Packaging Defects	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.