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.
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
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Duloxetine delayed-release capsules are used to treat major depressive disorder, generalized anxiety disorder, and neuropathic pain. The product is manufactured in Spain for distribution in the US.
N-nitroso-duloxetine impurity above FDA interim limit during CGMP evaluation could pose safety risks to patients.
This recall is not described as part of a broader industry pattern in the notice.
Immediate action is required to halt potential exposure to patients who may be taking the affected product.
FDA recall page for D-0580-2025; Breckenridge Pharmaceutical contact details in recall notice
Recall processing and replacement or refunds follow company communications; typical timelines range weeks to months
Keep bottle packaging, receipts, and recall notices; document communications and any adverse reactions
Product: Duloxetine Delayed-Release Capsules, USP, 60 mg. Quantity: 1,856 bottles. Manufacturer: Towa Pharmaceutical Europe, S.L., Martorelles, Spain. Importer/Distributor for US: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-032-10. Lot: 240539C. Expiration: 1/31/2027. Sold to: Distribution in New Jersey, Arizona, Indiana.
No specific patient injuries or adverse events are reported 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.
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.