Reported Feb 26, 2025 · Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only
- Manufactured forNorthstar Rx LLC., Memphis, TN 38141
- Manufactured byGlenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01
- Lot codes and dates
- Lot Numbers
192332701923327819233285Exp.: 7/202519233806Exp.: 8/202519240954Exp.: 2/202619241854Exp.: 4/2026
- Lot Numbers
- Amount recalled
- 58,368 bottles
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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