Warning
Asclemed USA Inc. Recalls Duloxetine DR Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0555-2026Drug / Pharmaceutical
Asclemed USA Inc. Recalls Duloxetine DR Capsules
Asclemed USA Inc. · Class II — Moderate Risk
Product Description
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.
Reason for Recall
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Asclemed USA Inc. has recalled a pharmaceutical product that the FDA classified as Class II affecting 50 bottles. The recall was initiated on May 14, 2026. CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. It was distributed in US Nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.