The Recall Desk
HighFDA (Drugs)·D-0234-2025·Announced 2025-02-26

Atomoxetine capsules recalled due to elevated N-nitroso impurity

Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.

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 with no reported illnesses or injuries. The hazard is chemical contamination—N-nitroso impurity above FDA limits in a prescription pharmaceutical. Scores 3 per rubric criterion for risk-of-harm products where injury has not been reported.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 40 mg supplied in 30-capsule bottles. The affected lot numbers are 19234109 (expires 9/2025), 19234897 (expires 11/2025), 19240501 (expires 1/2026), 19241489 (expires 3/2026), and 19241806 (expires 4/2026). Approximately 190,320 bottles have been distributed nationwide within the United States.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. Specifically, testing identified N-Nitroso Atomoxetine impurity in some lots at concentrations exceeding FDA-recommended limits.

Patients currently taking Atomoxetine from affected lots should consult their healthcare provider or pharmacist before taking any action. Do not stop taking medication without medical guidance. Healthcare providers and pharmacists should verify inventory against the recalled lot numbers and expiration dates and quarantine any affected product.

The recalled product

Product
ATOMOXETINE (ATOMOXETINE)
Brand
ATOMOXETINE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
Affected units
190,320

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: 19234109
  • Exp.: 9/2025
  • 19234897
  • Exp.: 11/2025
  • 19240501
  • Exp.: 1/2026
  • 19241489
  • Exp.: 3/2026
  • 19241806
  • Exp.: 4/2026.

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 →