Atomoxetine Capsules Recalled for Manufacturing Impurity Above Limits
Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.
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 with no reported illnesses or injuries. N-Nitroso Atomoxetine is a genotoxic impurity above regulatory limits, representing a high-risk manufacturing defect where potential harm has not yet been reported.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 60 mg bottles due to manufacturing deviations. The products contain N-Nitroso Atomoxetine impurity at levels above the FDA-recommended limit.
The recall affects approximately 53,952 bottles distributed nationwide. The affected lot numbers are 19234630 (expiration 10/2025) and 19240529 (expiration 1/2026).
Consumers in possession of the recalled product should contact their pharmacist or healthcare provider for further guidance.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- nitrosamine-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 (4)
- Lot Numbers: 19234630
- Exp.: 10/2025
- 19240529
- Exp.: 1/2026.
UPCs (5)
- 0316714760018
- 0316714755014
- 0316714756011
- 0316714761015
- 0316714757018
Distribution
Distributed nationwide across the United States.
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