Reported Feb 26, 2025 · Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ,…
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, 80 mg, 30 capsule bottles, Rx Only
- Manufactured forGlenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30
- Lot codes and dates
- Lot Numbers
19234153Exp.: 9/20251923490019234929Exp.: 11/20251924093619240942Exp.: 2/20261924319919243190Exp.:7/20261924401319244014Exp.: 9/2026
- Lot Numbers
- Amount recalled
- 87,600 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Glenmark Pharmaceuticals Inc., USA recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.