Breckenridge Pharmaceutical recalls duloxetine delayed-release capsules due to CGMP deviations raising N-nitroso-duloxetine impurity above interim limit. The bottles were distributed to Arizona, Indiana and New Jersey. Consumers should stop using the product and contact their healthcare provider for guidance.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed 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
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Duloxetine delayed-release capsules are prescribed antidepressant medications used for treating major depressive disorder, generalized anxiety disorder, and other conditions.
Manufacturing deviations led to a potentially harmful impurity, N-nitroso-duloxetine, above interim limits, which may pose health risks with prolonged exposure.
This recall is not described as part of a broader industry pattern in the provided data.
The recall affects 3,591 bottles distributed to three states, with guidance to stop use immediately and seek medical guidance.
FDA recall page for enforcement report D-0621-2025.
Recall remedies typically processed within weeks to months; expect notices by Breckenridge through official channels.
Keep recall notices, bottle labels, lot numbers, and correspondence with Breckenridge for refunds or replacements
Product: Duloxetine Delayed-Release Capsules, USP, 30 mg. Bottle size: 1,000 capsules. Rx Only. NDC: 82009-030-10. Manufacturer: Towa Pharmaceutical Europe S.L., Martorelles ( Barcelona ), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. Quantity: 3,591 bottles. Lot: 240927C. Expiration: 04/30/2027. Distributed to: AZ, IN, NJ.
No specific injuries or incidents are described in the recall notice.
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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.
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.
Quallent Pharmaceuticals Health LLC recalls 1,856 bottles of Duloxetine delayed-release capsules due to CGMP deviations and an impurity above FDA interim limits. The recall is active as of August 20, 2025. Patients and providers should stop use and contact Breckenridge Pharmaceutical or a healthcare provider for guidance.