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Drug FDA Class II Ongoing cGMP deviation

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

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, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

ATOMOXETINE · 175,920 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: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 29, 2025
  2. Published
    Feb 26, 2025
Recall number
D-0233-2025
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.