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Duloxetine Delayed-Release Capsules 30mg
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DRUG RECALLMODERATE

Duloxetine Delayed-Release Capsules 30mg

Breckenridge Pharmaceutical is recalling 30mg Duloxetine capsules due to levels of N-nitroso-duloxetine impurity exceeding FDA limits.

What to do

Contact your healthcare provider or pharmacist to discuss alternative treatment options. Do not stop taking your medication without consulting a medical professional.

Posted
Updated
Agency
Firm
Breckenridge Pharmaceutical, Inc.
Recall ID
99108
Status
ONGOING

Why it was recalled

Breckenridge Pharmaceutical is recalling specific lots of Duloxetine Delayed-Release Capsules, 30mg, due to the presence of N-nitroso-duloxetine impurity levels exceeding the FDA-recommended interim limit. This recall involves 1000-count bottles.

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

StrengthNDC / UPC
30 mgNDC 51991-747-10
60 mgNDC 51991-748-90

Other recent recalls from Breckenridge Pharmaceutical, Inc.

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Editorial summary by Recall Canary · last updated 2026-06-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification