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Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Glenmark Pharmaceuticals Inc., USA
The product
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
Details
- Units affected
- 133,824 bottles
- Recall date
- January 29, 2025
- Brand
- Glenmark Pharmaceuticals Inc., USA
Nationwide within the U.S
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine