Towa Pharmaceutical Europe recalled 1,856 bottles of Duloxetine delayed-release capsules on July 25, 2025. The recall follows the discovery of N-nitroso-duloxetine impurity exceeding FDA limits. Consumers should stop using the product immediately and seek guidance.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Consumers and healthcare providers should stop using this product immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for guidance. Notification method: Letter
The recall involves Duloxetine Delayed-Release Capsules, USP, 60 mg, with 1,000 capsules per bottle. The product, NDC 82009-032-10, was manufactured in Spain and distributed in New Jersey, Arizona, and Indiana.
The recall stems from CGMP deviations, specifically the presence of N-nitroso-duloxetine impurity above FDA recommended interim limits. This impurity poses potential health risks.
As of now, there are no reported incidents or injuries associated with this recall. The recall is classified as Class II.
Stop using the product immediately. Consumers should contact Breckenridge Pharmaceutical, Inc. or their 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-0580-2025.
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