Breckenridge Pharmaceutical, Inc. recalled 7,389 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations and the presence of N-nitroso-duloxetine impurity above FDA limits. Consumers should stop using the product immediately and contact healthcare providers for guidance.
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 1000-capsule bottles. The affected lot numbers include 240534C with an expiration date of January 2027 and 240977C with an expiration date of April 2027. These products were distributed nationwide in the United States.
The product contains N-nitroso-duloxetine, an impurity that exceeds FDA recommended limits. This impurity could potentially pose health risks to consumers.
No specific injuries or incidents have been reported in connection with this recall. The recall was initiated due to regulatory compliance issues rather than direct consumer reports.
Stop using Duloxetine Delayed-Release Capsules immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for further guidance and potential alternatives.
For more information, call Breckenridge Pharmaceutical, Inc. at 1-800-XXX-XXXX or visit their website.
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