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Drug FDA Class II Ongoing cGMP deviation

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

Glenmark Pharmaceuticals Inc., USA Published Feb 26, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Hazards

N-Nitroso Atomoxetine · primary

Affected products (1)

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

ATOMOXETINE · 87,600 bottles

NDC: 68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271, 68462-265-30, 68462-265-23, 68462-266-30, 68462-266-23, 68462-267-30, 68462-267-23, 68462-268-30, 68462-268-23, 68462-269-30, 68462-269-23, 68462-270-30, 68462-270-23, 68462-271-30, 68462-271-51
Lot codes: Numbers
Code info: Lot Numbers: 19234153, Exp.: 9/2025; 19234900, 19234929, Exp.: 11/2025; 19240936, 19240942, Exp.: 2/2026; 19243199, 19243190, Exp.:7/2026; 19244013, 19244014, Exp.: 9/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 29, 2025
  2. Published
    Feb 26, 2025
Recall number
D-0236-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.