Towa Pharmaceuticals recalled 3,397 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations resulting in N-nitroso-duloxetine levels exceeding FDA limits. Consumers must stop using the product immediately.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Consumers and healthcare providers should stop using this product immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for guidance
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The recall involves Duloxetine Delayed-Release Capsules, USP, 60 mg, sold in 1,000-capsule bottles. The affected lot numbers are 240947C and 240962C with an expiration date of April 2027.
The recall is due to the presence of N-nitroso-duloxetine impurity above acceptable FDA limits. This impurity is classified as a potential carcinogen.
Consumers and healthcare providers should stop using the recalled Duloxetine capsules immediately. Contact Breckenridge Pharmaceutical, Inc. or a healthcare provider for further guidance.
For more information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0215-2026.
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