Sertraline recalls
The FDA has published 4 recalls involving Sertraline since 2014. The latest was reported on 17 Dec 2025. Legacy Pharmaceutical Packaging 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 recalls4since 2014
Last 12 months1reported
Class I00% of total
Ongoing2latest 17 Dec 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 100%Class III 0 0%
Why sertraline is recalled
Companies
By year
Ongoing sertraline recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
All sertraline recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
| Drug | CLASS II | sertraline HCl tablets, 25 mg recalled by Greenstone | Greenstone | Other | Nationwide |
| Drug | CLASS II | Sertraline HCL Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
Should you stop taking Sertraline?
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.