Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination
Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if 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 for a prescription drug with confirmed impurity contamination above regulatory limits. N-Nitroso Atomoxetine poses genotoxic and carcinogenic risks, qualifying as a risk-of-harm product where no injury has been reported, meeting the High severity threshold.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA, is recalling Atomoxetine Capsules, USP, 80 mg (30-capsule bottles) distributed nationwide. The recall affects approximately 87,600 bottles due to CGMP deviations discovered during manufacturing quality control.
The affected lots contain N-Nitroso Atomoxetine impurity at levels above FDA-recommended limits. This impurity was identified during quality control measures and prompted the Class II recall.
Patients taking Atomoxetine 80 mg should check if their medication is from one of the recalled lots, which include lot numbers 19234153 (expiring 9/2025), 19234900 and 19234929 (expiring 11/2025), 19240936 and 19240942 (expiring 2/2026), 19243199 and 19243190 (expiring 7/2026), and 19244013 and 19244014 (expiring 9/2026). Patients with affected medication should consult their healthcare provider or pharmacist for guidance on treatment.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- 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 (14)
- Lot Numbers: 19234153
- Exp.: 9/2025
- 19234900
- 19234929
- Exp.: 11/2025
- 19240936
- 19240942
- Exp.: 2/2026
- 19243199
- 19243190
- Exp.:7/2026
- 19244013
- 19244014
- Exp.: 9/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
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