Class II
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Recall number
- D-0241-2025
- Report date
- February 26, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Generic names
- ATOMOXETINE
- Brand names
- ATOMOXETINE
- Product NDCs
- 16714-755, 16714-756, 16714-757, 16714-758, 16714-759, 16714-760, 16714-761
Code and lot information
Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.
Distribution
Nationwide within the U.S
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.