Atomoxetine recalls
Atomoxetine products have been recalled 8 times, most recently on 27 May 2026. The recalling company is usually Glenmark Pharmaceuticals Inc., USA. The most common reason is nitrosamine impurity.
Total recalls8since 2025
Last 12 months1reported
Class I00% of total
Ongoing8latest 27 May 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 8 100%Class III 0 0%
Why atomoxetine is recalled
Companies
Product types
By year
Ongoing atomoxetine recalls
8 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atomoxetine Capsules HCL in unit dose foil strip, strips recalledAtomoxetine | Safecor Health | Labeling Errors | TX |
| Drug | CLASS II | Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 80 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 25 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
All atomoxetine recalls, newest first
8 totalAbout 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.