Reported Dec 10, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals…
Breckenridge Pharmaceutical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc. · 200 Connell Dr Ste 4200 · Berkeley Heights, NJ · 07922-2805
Is this the product you have?
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only
- Manufactured byTowa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain
- Distributed byBreckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10
- Lot codes and dates
Lot #: 240534CExp. Date 01/2027240977CExp. Date 04/2027
- Amount recalled
- 7389 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
This product could cause temporary or reversible health problems — stop using it.
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