Prescription Atomoxetine capsules recalled for N-Nitroso impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.
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: This is an FDA Class II recall of a pharmaceutical product due to manufacturing deviations and a chemical impurity above FDA-recommended limits. N-Nitroso compounds are a regulatory concern, but no illnesses or injuries are reported in the source, which per the rubric caps the score at High.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP 25 mg in 30-capsule bottles distributed nationwide. The recall was issued due to manufacturing deviations identified during quality control testing, specifically the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits.
N-Nitroso compounds are a regulatory concern in pharmaceutical manufacturing. The presence of this impurity above established FDA limits prompted the Class II recall affecting approximately 175,920 bottles.
Eleven lot numbers are affected, with expiration dates ranging from August 2025 to September 2026. Affected lots include: 19233792 (Exp. 8/2025), 19233795 (Exp. 8/2025), 19234258 (Exp. 9/2025), 19240912 (Exp. 2/2026), 19241476 and 19241477 (Exp. 3/2026), 19242599 (Exp. 6/2026), 19243162 and 19243163 (Exp. 7/2026), and 19243884 and 19243887 (Exp. 9/2026).
Consumers who have this medication should contact their pharmacy or healthcare provider. The FDA is overseeing the recall.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- n-nitroso-compound
- manufacturing-deviation
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 (18)
- Lot Numbers: 19233792
- Exp.: 8/2025
- 19233795
- 19234258
- Exp.: 9/2025
- 19240912
- Exp.: 2/2026
- 19241476
- 19241477
- Exp.: 3/2026
- 19242599
- Exp.: 6/2026
- 19243163
- 19243162
- Exp.:7/2026
- 19243884
- 19243887
- Exp.:9/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
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