D-0555-2026 Class II Ongoing
FDA drug recall D-0555-2026 was initiated by Asclemed USA Inc. on May 14, 2026 and is designated Class II. Reason for recall: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. The recall status is ongoing. Affected quantity: 50 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 10, 2026
- Initiation Date
- May 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 bottles
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.
Distribution Pattern
US Nationwide.
Code Information
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026