Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling 39,168 bottles of Atomoxetine 100 mg capsules nationwide due to manufacturing deviations that resulted in N-Nitroso impurity exceeding FDA recommended limits. No illnesses have been reported.
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 a Class II pharmaceutical recall for N-Nitroso Atomoxetine impurity above FDA recommended limits, which constitutes a risk-of-harm product given the carcinogenic potential of nitroso compounds. The source reports no illnesses or injuries, placing the score at the rubric maximum of 3 for risk-of-harm products without reported harm.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 39,168 bottles of Atomoxetine Capsules, USP 100 mg, distributed nationwide. The affected bottles are identified by lot numbers 19234955, 19234956 (expiring 11/2025), 19240971 (expiring 2/2026), and 19241864 (expiring 4/2026), with NDC 68462-271-30.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. N-Nitroso compounds are a class of chemicals of concern in pharmaceutical manufacturing.
This prescription medication may have been dispensed to patients nationwide through pharmacy channels. Patients currently taking this medication should not stop taking it without consulting their healthcare provider, as abruptly discontinuing atomoxetine can have health consequences.
Patients with affected lot numbers should contact their pharmacy or healthcare provider to discuss their options, which may include exchanging their medication for an unaffected lot. Healthcare providers and patients can report adverse events to the FDA through MedWatch.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- 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 (7)
- Lot Numbers: 19234955
- 19234956
- Exp.: 11/2025
- 19240971
- Exp.: 2/2026
- 19241864
- Exp.: 4/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
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