ATOMOXETINE HYDROCHLORIDE Recall D-0236-2025
Description: Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
ATOMOXETINE HYDROCHLORIDE Recall D-0236-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0236-2025 |
| Event ID | 96194 |
| Brand | ATOMOXETINE |
| Generic Name | ATOMOXETINE |
| Manufacturer | ATOMOXETINE |
| Original Package? | 1 |
| Active Substance | ATOMOXETINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide within the U.S |
| Quantity | 87,600 bottles |
| Recall Reason | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250226 |
| Product NDC | 68462-265 68462-266 68462-267 |
| Drug UPC | 0368462270301 |
| Recall Initiation Date | 20250129 |
| Report Date | 20250226 |
| Classification Date | 20250220 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 57WVB6I2W0 |
| Drug Application Number | ANDA079019 |
| Structured Product Labeling (SPL ID) | 84dc1413-a85b-41f6-a3e3-6e76c01f6803 |
| Structured Product Labeling (SPL Set ID) | 0ab8d905-e890-4e91-a730-3e5d12f5c23f |
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