Drug recall
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical…
FDA recall event 97276 · Class II · Breckenridge Pharmaceutical, Inc.
Key facts
| Event ID | 97276 |
|---|---|
| Recall numbers | D-0552-2025 |
| Recalling firm | Breckenridge Pharmaceutical, Inc. |
| Product type | Drugs |
| Products | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit |
| Initiation date | Jul 15, 2025 |
| Report date | Aug 13, 2025 |
| City | Berkeley Heights |
| State | NJ |
| Country | United States |
| FEI number | 3029465821 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: