FDA Drug recall D-0235-2025
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India,…
- FDA Drug
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India,… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0235-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-29 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Identifiers
| ndc | 68462-265-30 |
|---|---|
| ndc | 68462-265-23 |
| ndc | 68462-266-30 |
| ndc | 68462-266-23 |
| ndc | 68462-267-30 |
| ndc | 68462-267-23 |
| ndc | 68462-268-30 |
| ndc | 68462-268-23 |
| ndc | 68462-269-30 |
| ndc | 68462-269-23 |
| ndc | 68462-270-30 |
| ndc | 68462-270-23 |
| ndc | 68462-271-30 |
| ndc | 68462-271-51 |
| code_info | Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0235-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.