Duloxetine Delayed-Release Capsules USP — Class II drug recall D-0388-2025
Ongoing recall by Breckenridge Pharmaceutical, Inc, reported 2025-04-30, distributed nationwide. CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
| Recall number | D-0388-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc, Berlin, CT, United States |
| Recall initiated | 2025-04-14 |
| Classified | 2025-04-22 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 343,344 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 51991-0746, 51991-0746-05, 51991-0746-06, 51991-0746-90, 51991-0747, 51991-0747-10, 51991-0747-33, 51991-0747-90, 51991-0748, 51991-0748-10, 51991-0748-33, 51991-0748-90, 51991-0750, 51991-0750-05, 51991-0750-10, 51991-0750-33, 51991-0750-90 |
| Lot numbers | 230201C, 230288C, 230471C |
| Expiration dates | 2026-01 |
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim 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-0388-2025. 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.