Atomoxetine recalls

The FDA has published 18 recalls involving Atomoxetine since 2014. The latest was reported on 27 May 2026. Most were for nitrosamine impurity. Glenmark Pharmaceuticals Inc., 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 recalls18since 2014

Last 12 months1reported

Class I00% of total

Ongoing15latest 27 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 14Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 18 100%Class III 0 0%

Why atomoxetine is recalled

Companies

By year

202616%
20251478%
2014317%

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 recalledAtomoxetine	Safecor Health	Labeling Errors	TX
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide

All atomoxetine recalls, newest first

18 total

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Atomoxetine Capsules HCL in unit dose foil strip, strips recalledAtomoxetine	Safecor Health	Labeling Errors	TX
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 25 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 80 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 18 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 25 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 18 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
26 Feb 2025Drug	CLASS II	Atomoxetine Capsules, USP, 80 mg recalled by Glenmark PharmaceuticalsAtomoxetine	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
29 Jan 2014Drug	CLASS II	Atomoxetine HCL, Capsule, 80 mg recalled by Aidapak Services	Aidapak Services	Packaging Defects	4 states
29 Jan 2014Drug	CLASS II	Atomoxetine HCL, Capsule, 18 mg recalled by Aidapak Services	Aidapak Services	Packaging Defects	4 states
29 Jan 2014Drug	CLASS II	Atomoxetine HCL, Capsule, 40 mg recalled by Aidapak Services	Aidapak Services	Packaging Defects	4 states

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.