FDA Drugs recall ·
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle ( recall
- Recall number
- D-0100-2026
- Date
- (initiated October 9, 2025)
- 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
- 172,263 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Why was it recalled?
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
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
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Distribution
U.S. Nationwide
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-0100-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.