Atomoxetine Prescription Capsules Recalled for Impurity Above FDA Recommended Level
Glenmark Pharmaceuticals is recalling 58,368 bottles of Atomoxetine Capsules 100 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. The recall affects bottles distributed nationwide.
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 3/5 (High).
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 potential health risk from N-nitroso compound impurity. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP 100 mg due to the presence of N-Nitroso Atomoxetine impurity exceeding FDA-recommended limits. This represents a Good Manufacturing Practice (CGMP) deviation.
The recall encompasses 58,368 bottles distributed nationwide within the United States. The product was manufactured for Northstar Rx LLC, Memphis, TN 38141, and manufactured by Glenmark Pharmaceuticals Ltd., Goa, India, with NDC 16714-761-01.
Affected lot numbers are: 19233270, 19233278, 19233285 (expiring 7/2025); 19233806 (expiring 8/2025); 19240954 (expiring 2/2026); and 19241854 (expiring 4/2026).
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- Affected units
- 58,368
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 (10)
- Lot Numbers: 19233270
- 19233278
- 19233285
- Exp.: 7/2025
- 19233806
- Exp.: 8/2025
- 19240954
- Exp.: 2/2026
- 19241854
- Exp.: 4/2026.
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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