Atomoxetine Capsules — Class II drug recall D-0237-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-02-26, distributed nationwide. CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
| Recall number | D-0237-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-01-29 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 39,168 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68462-0265, 68462-0265-23, 68462-0265-30, 68462-0266, 68462-0266-23, 68462-0266-30, 68462-0267, 68462-0267-23, 68462-0267-30, 68462-0268, 68462-0268-23, 68462-0268-30, 68462-0269, 68462-0269-23, 68462-0269-30, 68462-0270, 68462-0270-23, 68462-0270-30, 68462-0271, 68462-0271-30, 68462-0271-51 |
| Lot numbers | 19234955, 19234956, 19240971, 19241864 |
| Expiration dates | 2025-11, 2026-02, 2026-04 |
Product
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0237-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.