Reported Nov 5, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC…
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, a.) 90-count
- bottle (NDC51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist
- byBreckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922
- Lot codes and dates
90-count- Lot # 240721CExp. 02/28/2027 1000-count- Lot #230286CExp.02/28/2026
- Amount recalled
- 172,263 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
This product could cause temporary or reversible health problems — stop using it.
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