Prescription Drug Recall: Atomoxetine Capsules Due to Impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.
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 risk-of-harm product containing N-nitroso impurity, a known genotoxic substance above regulatory limits. No illnesses or injuries are reported in the source text, consistent with a precautionary manufacturing-compliance recall.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 25 mg due to Current Good Manufacturing Practice (CGMP) deviations. The recalled product was manufactured by Glenmark Pharmaceuticals Ltd. in Goa, India and distributed nationwide within the United States under the brand name Atomoxetine with NDC 16714-757-01.
The recall was initiated because testing detected N-Nitroso Atomoxetine impurity levels that exceed the FDA recommended limit. This impurity resulted from manufacturing process deviations. A total of 133,824 bottles have been distributed.
The affected lot numbers are: 19232506, 19232397, 19232415 (Exp. 5/2025); 19233791 (Exp. 8/2025); 19234248 (Exp. 9/2025); 19240909 (Exp. 2/2026); 19242598 (Exp. 6/2026); 19243163, 19243122 (Exp. 7/2026); and 19243884 (Exp. 9/2026).
Consumers with affected bottles should not take the medication and should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacies should stop dispensing the affected lots immediately. This is a Prescription (Rx) only medication.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- nitrosamine-impurity
- pharmaceutical-contamination
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 (17)
- Lot Numbers: 19232506
- 19232397
- 19232415
- Exp.: 5/2025
- 19233791
- Exp.: 8/2025
- 19234248
- Exp.: 9/2025
- 19240909
- Exp.: 2/2026
- 19242598
- Exp.:6/2026
- 19243163
- 19243122
- Exp.: 7/2026
- 19243884
- Exp.: 9/2026.
UPCs (5)
- 0316714760018
- 0316714755014
- 0316714756011
- 0316714761015
- 0316714757018
Distribution
Distributed nationwide across the United States.
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