Atomoxetine Capsules Recalled Nationwide for N-Nitroso Impurity Exceeding FDA Limits
Glenmark Pharmaceuticals is recalling 119,040 bottles of Atomoxetine Capsules nationwide due to N-Nitroso Atomoxetine Impurity exceeding FDA recommended limits.
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 involving a pharmaceutical impurity above the FDA-recommended limit, representing a risk-of-harm situation per the severity rubric. No illnesses or hospitalizations have been reported.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 119,040 bottles of Atomoxetine Capsules, USP 18 mg nationwide due to the presence of N-Nitroso Atomoxetine Impurity above the FDA-recommended limit. This manufacturing deviation from current good manufacturing practice (CGMP) standards triggered the recall.
The affected product was manufactured by Glenmark Pharmaceuticals Ltd., Goa, India, for Northstar Rx LLC, Memphis, TN. The recall includes six specific lot numbers with expiration dates ranging from July 2025 to May 2026. These lots were distributed nationwide within the United States.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- n-nitroso
- impurity
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 (13)
- Lot Numbers: 19233228
- 19233227
- Exp.: 7/2025
- 19233757
- Exp.: 8/2025
- 19234229
- Exp.: 9/2025
- 19235090
- Exp.: 11/2025
- 19241471
- Exp.:3/2026
- 19242180
- Exp.: 5/2026.
UPCs (5)
- 0316714760018
- 0316714755014
- 0316714756011
- 0316714761015
- 0316714757018
Distribution
Distributed nationwide across the United States.
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