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.
Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Advertisement
Advertisement
Affected lots / codes — check yours against thisLot: 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.
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 359,676 bottles
- Distribution
- Nationwide within the United States
- Recall initiated
- June 4, 2026
- Classified
- June 8, 2026
- Initiation
- Voluntary: Firm initiated
Advertisement
Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0583-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0583-2026%22
Advertisement
Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →