Breckenridge recalls Duloxetine delayed-release capsules due to carcinogen risk

Duloxetine recall overview:

• Who: Breckenridge Pharmaceutical Inc. is recalling nearly 370,000 bottles of Duloxetine delayed-release capsules.
• Why: The recall is due to elevated levels of N-nitroso-duloxetine, a probable human carcinogen.
• Where: The recall is active across the United States.

Breckenridge Pharmaceutical is recalling nearly 370,000 bottles of Duloxetine delayed-release capsules due to potential contamination with N-nitroso-duloxetine, a substance classified as a probable carcinogen.

The Duloxetine recall affects bottles distributed nationwide in the United States, with the capsules manufactured by Towa Pharmaceutical Europe in Spain.

The recall impacts a significant number of bottles, with 14,729 bottles of the 30mg, 1,000-capsule size alone being affected.

The recalled Duloxetine delayed-release capsules were sold in various package sizes. The affected products include 90-capsule bottles with lot codes including 241074C and 240317 and expiration dates through May 2027. The recall also covers 1,000-capsule bottles of 30 mg capsules with lot code 241180C and 60 mg capsules with lot codes 240978C and 241052C, all of which have expiration dates of April 2027.

The recall, officially initiated on June 4, is categorized as a Class II recall, indicating that exposure to the product may lead to temporary or medically reversible adverse health consequences.

The presence of N-nitroso-duloxetine above FDA-recommended limits prompted the Duloxetine recall, as prolonged exposure to such impurities could increase cancer risk.

CGMP deviations led to N-nitroso-duloxetine impurity above FDA’s recommended limit

Breckenridge Pharmaceutical voluntarily recalled the Duloxetine delayed-release capsules after discovering deviations from Current Good Manufacturing Practices (CGMP) that resulted in the presence of N-nitroso-duloxetine impurity above the FDA’s recommended limit.

The recall notice emphasizes that the Duloxetine delayed-release capsules, used to treat conditions like depression and anxiety, should not be consumed if they belong to the affected lots.

For more information about the Duloxetine recall, consumers can contact Breckenridge Pharmaceutical at (800) 466-2700. The company has not issued a press release but has provided information through direct communication with consignees.

There have been no reports of illness related to the recall so far. The company is not currently facing legal action over the Duloxetine recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Recently, Teva Pharmaceuticals, Granules USA and Heritage Pharmaceuticals agreed to a combined $5.55 million settlement to resolve claims their metformin products were contaminated with cancer-causing N-nitrosodimethylamine.

Are you affected by the Duloxetine recall? Let us know in the comments.

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