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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Duloxetine Delayed-Release Capsules are prescribed for treating depression, anxiety, and certain types of pain. Patients value this medication for its effectiveness in managing chronic conditions.
The presence of N-nitroso-duloxetine in the product raises cancer risk concerns, as this impurity exceeds FDA safety limits. Consumers using the affected capsules may face potential long-term health risks.
This recall is not part of a broader industry pattern.
Consumers who have purchased this product should stop use immediately to mitigate health risks. They may experience inconvenience in needing to find alternative medications.
Lot numbers and expiration dates are typically found on the label or the bottom of the bottle.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep receipts, communication records, and take photos of the product as evidence.
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.
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