Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.
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 recall for N-Nitroso impurity above FDA recommended limits. N-nitroso compounds are known health hazards with potential genotoxic properties. This qualifies as a risk-of-harm product without reported adverse events.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 18 mg, nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recalled product contains N-Nitroso Atomoxetine impurity at levels above FDA recommended limits.
The recall affects 56,208 bottles distributed nationwide. Affected lot numbers include 19233756 (expiration 8/2025), 19235111 (expiration 11/2025), 19242167 (expiration 5/2026), and 19242180 (expiration 5/2026). The product is identified by NDC 68462-266-30 and related package NDCs.
Consumers and healthcare providers with affected bottles should contact their healthcare provider or pharmacist before discontinuing the medication. Patients should not stop taking their medication without medical guidance.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- impurity
- n-nitroso
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 (8)
- Lot Numbers: 19233756
- Exp.: 8/2025
- 19235111
- Exp.: 11/2025
- 19242167
- Exp.: 5/2026
- 19242180
- Exp.: 5/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
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