Atomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The nationwide recall affects 80,160 bottles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with no reported illnesses or injuries. The presence of N-Nitroso Atomoxetine impurity above FDA recommended limits represents a risk-of-harm product, but without reported injury, this meets the criteria for Score 3.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 60 mg throughout the United States due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. This is a Class II recall issued by the FDA.
The issue was identified as a current Good Manufacturing Practice (CGMP) deviation during manufacturing. N-Nitroso Atomoxetine is an impurity that may form during the manufacturing process and was detected at levels exceeding FDA guidelines. The recall affects approximately 80,160 bottles of the affected lot numbers.
Affected lot numbers are: 19234630 (expiration 10/2025), 19240528 and 19240529 (expiration 1/2026). These bottles were distributed to consumers nationwide.
Patients currently taking Atomoxetine from these affected lots should contact their healthcare provider or pharmacist for guidance before taking any action regarding their medication.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- n-nitroso-impurity
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: 19234630
- Exp.: 10/2025
- 19240528
- 19240529
- Exp.: 1/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
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