Reported Jun 17, 2026 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules…
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, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist
- byBreckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922
- Lot codes and dates
- Lot
a) 241074CExp. Date May 2027240317240318240315C240373C240370C240375C240413CExp. Date February 2027240316Exp. Date January 2027232311Exp. Date November 2026b) 240978C241052CExp. Date April 2027
- Lot
- Amount recalled
- 359,676 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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