Reported Jun 17, 2026 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical…
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, 30mg, 1000 Capsule bottles, Rx only, Manufactured
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain
- Distributed byBreckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
- Lot codes and dates
- Lot
241180CExp. Date April 2027
- Lot
- Amount recalled
- 14,729 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 FDA recommended interim limit
This product could cause temporary or reversible health problems — stop using it.
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