Atomoxetine capsules recalled due to elevated N-nitroso impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall with no reported illnesses or injuries. The hazard is chemical contamination—N-nitroso impurity above FDA limits in a prescription pharmaceutical. Scores 3 per rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 40 mg supplied in 30-capsule bottles. The affected lot numbers are 19234109 (expires 9/2025), 19234897 (expires 11/2025), 19240501 (expires 1/2026), 19241489 (expires 3/2026), and 19241806 (expires 4/2026). Approximately 190,320 bottles have been distributed nationwide within the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. Specifically, testing identified N-Nitroso Atomoxetine impurity in some lots at concentrations exceeding FDA-recommended limits.
Patients currently taking Atomoxetine from affected lots should consult their healthcare provider or pharmacist before taking any action. Do not stop taking medication without medical guidance. Healthcare providers and pharmacists should verify inventory against the recalled lot numbers and expiration dates and quarantine any affected product.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- Affected units
- 190,320
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 (10)
- Lot Numbers: 19234109
- Exp.: 9/2025
- 19234897
- Exp.: 11/2025
- 19240501
- Exp.: 1/2026
- 19241489
- Exp.: 3/2026
- 19241806
- Exp.: 4/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same brand · ATOMOXETINE
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- HighAtomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity
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- HighAtomoxetine Capsules Recalled Nationwide for N-Nitroso Impurity Exceeding FDA Limits
FDA (Drugs) · 2025-02-26
- HighAtomoxetine 40 mg Capsules Recalled for N-Nitroso Impurity Above Limits
FDA (Drugs) · 2025-02-26
- HighAtomoxetine Prescription Capsules Recalled for Impurity Above FDA Recommended Level
FDA (Drugs) · 2025-02-26
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