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Duloxetine DR Capsules recall

Asclemed USA Inc. recalled Duloxetine DR Capsules on June 10, 2026 because of cGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. It was sold nationwide.

Why it was recalled

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

What's recalled

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

Quantity: 50 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 notice

Details

Company
Asclemed USA Inc., Torrance, CA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0555-2026
Source
U.S. Food and Drug Administration

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