Agency classClass IIOur severity:High FDA (Drugs)·D-0242-2025·Announced 2025-02-26

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.

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: 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
Affected units: 53,952

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.

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 →

Same brand · ATOMOXETINE

Severe
Atomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
High
Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination
FDA (Drugs) · 2025-02-26
High
Atomoxetine capsules recalled due to elevated N-nitroso impurity
FDA (Drugs) · 2025-02-26
High
Atomoxetine Capsules Recalled for Elevated Nitrosamine Impurity
FDA (Drugs) · 2025-02-26
High
Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits
FDA (Drugs) · 2025-02-26

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

See all →

Moderate
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FDA (Drugs) · 2026-08-05
Moderate
Alyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
Moderate
Ondansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
Critical
Frozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
Moderate
Bisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10

Same hazard · nitrosamine impurity