Atomoxetine Capsules Recalled for Elevated Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling 70,032 bottles of Atomoxetine Capsules nationwide due to N-Nitroso 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: FDA Class II recall without reported illnesses or injuries. N-Nitroso Atomoxetine impurity exceeds FDA limits, representing a manufacturing quality and potential health risk without documented harm to date.
Plain-English summary
Glenmark Pharmaceuticals Inc. (USA) is recalling 70,032 bottles of Atomoxetine Capsules, USP, 10 mg nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. The impurity was discovered during manufacturing quality reviews and represents a deviation from current good manufacturing practices (CGMP).
The recalled product was distributed nationwide. Affected lot numbers are: 19232368 (Expires May 2025), 19235088 (Expires November 2025), 19241447 (Expires March 2026), and 19243146 (Expires July 2026). Consumers can check their bottle's lot number to determine if their supply is affected.
Patients currently taking this medication should contact their pharmacy or healthcare provider regarding their specific supply and appropriate next steps. No illnesses have been reported to date in connection with this recall.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Affected units
- 70,032
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: 19232368
- Exp:5/2025
- 19235088
- Exp.: 11/2025
- 19241447
- Exp.: 3/2026
- 19243146
- Exp.: 7/2026.
UPCs (7)
- 0368462265307
- 0368462270301
- 0368462267301
- 0368462271308
- 0368462268308
- 0368462269305
- 0368462266304
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
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- HighAtomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits
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- ModerateAtomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits
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- HighAtomoxetine Prescription Capsules Recalled for Impurity Above FDA Recommended Level
FDA (Drugs) · 2025-02-26
- HighAtomoxetine capsules recalled due to elevated N-nitroso impurity
FDA (Drugs) · 2025-02-26
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