Duloxetine Delayed-Release Capsules USP — Class II drug recall D-0212-2025
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2025-02-05, distributed nationwide. CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above
| Recall number | D-0212-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2025-01-13 |
| Classified | 2025-01-29 |
| Reported by FDA | 2025-02-05 |
| Terminated | 2026-03-05 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00904-7043-04, 00904-7043-61 |
| Expiration dates | 2025-01 |
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Reason for recall
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake 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-0212-2025. 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.