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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 120,000
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.
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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