Atomoxetine Capsules Recalled Due to N-Nitroso Impurity Contamination
Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing quality deviation with no reported illnesses or adverse events. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Atomoxetine Capsules, USP, 80 mg. Approximately 58,416 bottles were distributed nationwide in the United States. The product was manufactured by Glenmark Pharmaceuticals Ltd. in Goa, India and distributed under the brand name Atomoxetine by Northstar Rx LLC in Memphis, Tennessee.
The recall was initiated due to a Current Good Manufacturing Practices (CGMP) deviation involving the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits.
The affected lot numbers are: 19233234 and 19233253 (expiration 7/2025), 19234154 (expiration 9/2025), 19243185 (expiration 7/2026), 19243951 and 19243974 (expiration 9/2026). Patients who have obtained this medication are advised to verify the lot number on their prescription bottles.
Patients currently taking this medication should contact their healthcare provider or pharmacist regarding affected product and whether their medication needs to be replaced.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — ADHD Medication
- Hazard
- n-nitroso-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot Numbers: 19233234
- 19233253
- Exp.: 7/2025
- 19234154
- Exp.: 9/2025
- 19243185
- Exp.: 7/2026
- 19243951
- 19243974
- Exp.: 9/2026.
UPCs (5)
- 0316714760018
- 0316714755014
- 0316714756011
- 0316714761015
- 0316714757018
Distribution
Distributed nationwide across the United States.
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