Duloxetine Delayed-Release Capsules USP, 60mg recall
Breckenridge Pharmaceutical, Inc. recalled Duloxetine Delayed-Release Capsules USP, 60mg on May 13, 2026 because of cGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit. It was sold nationwide.
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
What's recalled
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Quantity: 165,761 90-count 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 in the USA - Status
- Ongoing
- Recall number
- D-0522-2026
- Source
- U.S. Food and Drug Administration
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