Atomoxetine recalls
Atomoxetine products have been recalled 15 times, most recently on 27 May 2026. The recalling company is usually Glenmark Pharmaceuticals Inc., U. The most common reason is nitrosamine impurity.
Total recalls15since 2025
Last 12 months1reported
Class I00% of total
Ongoing15latest 27 May 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 15 100%Class III 0 0%
Why atomoxetine is recalled
Companies
Product types
By year
Ongoing atomoxetine recalls
15 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atomoxetine Capsules HCL in unit dose foil strip, strips are recalledAtomoxetine | Safecor Health | Labeling Errors | TX |
| Drug | CLASS II | Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
All atomoxetine recalls, newest first
15 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.