Duloxetine Delayed-Release Capsules recall
Breckenridge Pharmaceutical, Inc. recalled Duloxetine Delayed-Release Capsules on June 17, 2026 because of cGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. It was sold nationwide.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
What's recalled
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Quantity: 359,676 bottles
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide within the United States - Status
- Ongoing
- Recall number
- D-0583-2026
- Source
- U.S. Food and Drug Administration
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