CLASS II ONGOING Drug recall · Reported 26 Feb 2025 · FDA Enforcement Report
Atomoxetine Capsules, USP, 100 mg recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 29 Jan 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0237-2025
- FDA event ID
- 96194
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Atomoxetine
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- ADHD Medication
Timeline
| 29 Jan 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +22 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Which lots are affected?
Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 96194This product is part of a recall event; the main page for the event is Atomoxetine Capsules, USP, 80 mg recalled by Glenmark Pharmaceuticals.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Atomoxetine recalls
All 18| 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, 40 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 |