Atomoxetine 40 mg Capsules Recalled for N-Nitroso Impurity Above Limits
Glenmark Pharmaceuticals is recalling 233,040 bottles of Atomoxetine 40 mg capsules nationwide due to N-Nitroso impurity above FDA safety limits. Patients should check their medication bottles and contact their healthcare provider.
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 for N-Nitroso impurity exceeding safety limits. With no reported illnesses or injuries and the hazard being theoretical chemical contamination, this qualifies as a risk-of-harm product meriting a score of High (3) under the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 233,040 bottles of Atomoxetine 40 mg capsules. The medication was manufactured by Glenmark Pharmaceuticals Ltd. in Goa, India and distributed nationwide in the United States.
The recall was initiated due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This represents a Good Manufacturing Practice (CGMP) deviation identified by the manufacturer.
Affected lot numbers are: 19232540, 19232524, 19232553 (expiring May 2025); 19240510 (expiring January 2026); 19241489 (expiring March 2026); and 19243905, 19243935 (expiring September 2026). The product was distributed nationwide. Patients should verify the lot number and expiration date on their medication bottles and consult their healthcare provider for guidance regarding their current supply.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 233,040
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 (11)
- Lot Numbers: 19232540
- 19232524
- 19232553
- Exp.: 5/2025
- 19240510
- Exp.: 1/2026
- 19241489
- Exp.: 3/2026
- 19243905
- 19243935
- Exp.: 9/2026.
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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FDA (Drugs) · 2025-02-26
- ModerateAtomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits
FDA (Drugs) · 2025-02-26
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