Class II
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.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
- Recall number
- D-0555-2026
- Report date
- June 10, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Asclemed USA Inc.
- Generic names
- DULOXETINE
- Brand names
- DULOXETINE
- Product NDCs
- 76420-623, 76420-633, 76420-634, 76420-636
Code and lot information
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Distribution
US Nationwide.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.