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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Duloxetine Delayed-Release Capsules are a prescription medication used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain. Patients buy this medication to manage chronic pain and mood disorders.
The presence of N-nitroso-duloxetine above FDA limits raises concerns about potential carcinogenic effects, making the product unsafe for consumption.
This recall is not part of a broader industry pattern.
Consumers are urged to stop using the product immediately to avoid potential health risks. This recall can cause inconvenience for those relying on Duloxetine for treatment.
The lot number and expiration date are typically found on the label of the bottle.
Expect a timeline of 4-6 weeks for refund processing after contacting the manufacturer.
Keep receipts, correspondence, and any documentation related to the recall for your records.
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.
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