Atomoxetine Capsules recall: Impurity Out of Spec
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC…
Why was Atomoxetine Capsules recalled?
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.
- Product
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 190,320 bottles
- Distribution
- Nationwide within the U.S
- Recall date
- February 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)