Breckenridge recalls duloxetine 60mg capsules over impurity above FDA's recommended limit
The capsules contain N-nitroso-duloxetine, an impurity, at a level above the limit the FDA recommends, and the recall also cites manufacturing practice problems.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.
- Hazard
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Units
- 165,761 90-count bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 6, 2026
- Recall started
- April 21, 2026
- FDA enforcement report
- May 13, 2026
- Identifiers
- Codes: Lot: 241069C, Exp 05/31/2027
- FDA recall number: D-0522-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Reason for recall
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 165,761 90-count bottles
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