Asclemed USA Inc. recalls Duloxetine DR Capsules
- Recalling company
- Asclemed USA Inc.
- Product
- 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
- CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 14, 2026
- Reported
- Jun 10, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 50 bottles
- Lot / codes
- Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
- Company location
- Torrance, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0555-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0555-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.