Atomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a manufacturing deviation with no reported illnesses or injuries. The hazard is a chemical impurity exceeding FDA limits; the recall is precautionary in nature.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling approximately 120,000 bottles of Atomoxetine Capsules, USP 10 mg due to a manufacturing deviation. The recall was initiated because testing revealed the presence of N-nitroso Atomoxetine impurity exceeding FDA-recommended limits.
The affected product is distributed throughout the United States and is identified by the following lot numbers: 19232356 (expiring May 2025), 19233198 (July 2025), 19234213 and 19234232 (September 2025), 19241445 (March 2026), and 19243033 and 19243121 (July 2026).
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- impurity
- manufacturing-deviation
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 (12)
- Lot Numbers: 19232356
- Exp.: 5/2025
- 19233198
- Exp.: 7/2025
- 19234213
- 19234232
- Exp.: 9/2025
- 19241445
- Exp.: 3/2026
- 19243033
- 19243121
- Exp.: 7/2026.
UPCs (5)
- 0316714760018
- 0316714755014
- 0316714756011
- 0316714761015
- 0316714757018
Distribution
Distributed nationwide across the United States.
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