FDA Drugs recall ·
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only… recall
- Recall number
- D-0271-2025
- Date
- (initiated February 28, 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
- 11,125 bottles.
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
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#: 240098C, Expiration: 01/2027.
Distribution
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-0271-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.