Class II
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Recall number
- D-0583-2026
- Report date
- June 17, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Generic names
- DULOXETINE HYDROCHLORIDE
- Brand names
- DULOXETINE
- Product NDCs
- 51991-746, 51991-747, 51991-748, 51991-750
Code and lot information
Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
Distribution
Nationwide within the United States
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.