Atomoxetine recalls

The FDA has published 15 recalls involving Atomoxetine since 2025. The latest was reported on 27 May 2026. Most were for nitrosamine impurity. Glenmark Pharmaceuticals Inc., U 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 recalls15since 2025

Last 12 months1reported

Class I00% of total

Ongoing15latest 27 May 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 14 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 0

Severity split

Class I 0 0%Class II 15 100%Class III 0 0%

Why atomoxetine is recalled

Nitrosamine Impurity1493%
Labeling Errors17%

Companies

Glenmark Pharmaceuticals Inc., U1493%
Safecor Health17%

By year

202617%
20251493%

Ongoing atomoxetine recalls

15 active

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Atomoxetine Capsules HCL in unit dose foil strip, strips are recalledAtomoxetine	Safecor Health	Labeling Errors	TX
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide

All atomoxetine recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Atomoxetine Capsules HCL in unit dose foil strip, strips are recalledAtomoxetine	Safecor Health	Labeling Errors	TX
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 25 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 80 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 18 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 25 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide

Should you stop taking Atomoxetine?

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.