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.
No injuries or incidents have been reported related to this recall. However, the potential risk posed by the impurity is significant.
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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