Fluoxetine recalls
The FDA has published 10 recalls involving Fluoxetine since 2014. The latest was reported on 11 Jun 2025. Most were for potency & assay. Teva Pharmaceuticals USA 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 recalls 10 since 2014
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 0 latest 11 Jun 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%8 80%2 20%
Why fluoxetine is recalled
All fluoxetine recalls, newest first 10 total Reported Class Recall Company Reason Where 11 Jun 2025 Drug CLASS II Fluoxetine Tablets, USP, 20 mg recalled by Torrent Pharma Fluoxetine Torrent Pharma Nitrosamine Impurity Nationwide 11 Jun 2025 Drug CLASS II Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalled Fluoxetine Torrent Pharma Nitrosamine Impurity Nationwide 21 Feb 2018 Drug CLASS III Fluoxetine Tablets USP, 10 mg recalled by Teva Pharmaceuticals U Teva Pharmaceuticals USA Potency & Assay Nationwide 6 May 2015 Drug CLASS II Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals U Fluoxetine Teva Pharmaceuticals USA Potency & Assay Nationwide 6 May 2015 Drug CLASS II Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals U Fluoxetine Teva Pharmaceuticals USA Potency & Assay Nationwide 17 Dec 2014 Drug CLASS III Fluoxetine Capsules USP, 20 mg recalled by Sandoz Incorporated Sandoz Other AZ 7 May 2014 Drug CLASS II Fluoxetine Capsules, USP, 20 mg recalled by Legacy Pharmaceutical Fluoxetine Legacy Pharmaceutical Packaging Packaging Defects Nationwide 7 May 2014 Drug CLASS II Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals U Fluoxetine Teva Pharmaceuticals USA Other Nationwide 7 May 2014 Drug CLASS II Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals U Fluoxetine Teva Pharmaceuticals USA Packaging Defects Nationwide 22 Jan 2014 Drug CLASS II FLUoxetine HCl Capsule, 10 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states
Should you stop taking Fluoxetine?
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.