Reported Sep 17, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa…
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, 30 mg, 1,000 Capsules per bottle, Rx Only
- Manufactured byTowa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain
- Manufactured forQuallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands
- NDC82009-030-10
- Lot codes and dates
Lot 240927CExp 04/30/2027
- Amount recalled
- 3,591 bottles
Where it was sold
Why it was recalled
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
This product could cause temporary or reversible health problems — stop using it.
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