The Recall Desk
HighFDA (Drugs)·D-0235-2025·Announced 2025-02-26

Atomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity

Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The nationwide recall affects 80,160 bottles.

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 classification with no reported illnesses or injuries. The presence of N-Nitroso Atomoxetine impurity above FDA recommended limits represents a risk-of-harm product, but without reported injury, this meets the criteria for Score 3.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 60 mg throughout the United States due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. This is a Class II recall issued by the FDA.

The issue was identified as a current Good Manufacturing Practice (CGMP) deviation during manufacturing. N-Nitroso Atomoxetine is an impurity that may form during the manufacturing process and was detected at levels exceeding FDA guidelines. The recall affects approximately 80,160 bottles of the affected lot numbers.

Affected lot numbers are: 19234630 (expiration 10/2025), 19240528 and 19240529 (expiration 1/2026). These bottles were distributed to consumers nationwide.

Patients currently taking Atomoxetine from these affected lots should contact their healthcare provider or pharmacist for guidance before taking any action regarding their medication.

The recalled product

Product
ATOMOXETINE (ATOMOXETINE)
Brand
ATOMOXETINE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
Affected units
80,160

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 (5)

  • Lot Numbers: 19234630
  • Exp.: 10/2025
  • 19240528
  • 19240529
  • Exp.: 1/2026.

UPCs (7)

  • 0368462265307
  • 0368462270301
  • 0368462267301
  • 0368462271308
  • 0368462268308
  • 0368462269305
  • 0368462266304

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

Same brand · ATOMOXETINE

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

See all →

Same hazard · n nitroso impurity

See all →