FDA Drugs recall ·
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only… recall
- Recall number
- D-0162-2025
- Date
- (initiated December 6, 2024)
- Company / brand
- Breckenridge Pharmaceutical, Inc.
15 Massirio Dr Ste 201, Berlin, CT, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 76,968 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) 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 # 230077C, exp. date 11/2025
Distribution
Nationwide in the US
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-0162-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.