FDA Drugs recall ·
Duloxetine Delayed-Release Capsules, USP, 60mg… recall
- Recall number
- D-0583-2026
- Date
- (initiated June 4, 2026)
- Company / brand
- Breckenridge Pharmaceutical, Inc.
200 Connell Dr Ste 4200, Berkeley Heights, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 359,676 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0583-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.