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.
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 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
- n-nitroso-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 (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.
Related recalls
Same brand · ATOMOXETINE
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- HighAtomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination
FDA (Drugs) · 2025-02-26
- HighAtomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits
FDA (Drugs) · 2025-02-26
- HighAtomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits
FDA (Drugs) · 2025-02-26
- HighAtomoxetine Capsules Recalled for Manufacturing Impurity Above Limits
FDA (Drugs) · 2025-02-26
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27