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Duloxetine Delayed-Release Capsules 60mg
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DRUG RECALLMODERATE

Duloxetine Delayed-Release Capsules 60mg

Breckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.

What to do

Consult your healthcare provider or pharmacist regarding your medication. Do not stop taking your prescribed medication without first consulting a medical professional.

Recalled
Listed
Updated
Recall No.
D-0522-2026
Agency
FDA
Firm
Breckenridge Pharmaceutical, Inc.
Recall ID
98803
Status
ONGOING

Why it was recalled

Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules USP, 60mg, distributed nationwide. The recall is due to CGMP deviations and the presence of the impurity N-nitroso-duloxetine above the FDA recommended limit.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Duloxetine Delayed-Release Capsules USP

Lot code
241069C, 2027
Strength
60 mg
NDC / UPC
NDC 51991-748-90

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification