FDA Drug recall D-0233-2025
Atomoxetine Capsules, USP, 25 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, 25 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-0233-2025 |
| 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, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
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: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476,…Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026. |
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-0233-2025%22
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