Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 1,440 cartons of Esomeprazole Magnesium (generic Nexium) Delayed-Release Capsules in 20 mg and 40 mg strengths. The recall was issued after testing showed the medication failed to meet impurity and degradation specifications during long-term storage. No injuries or illnesses have been reported in connection with this issue, and the company is initiating the recall voluntarily. These products were distributed to pharmacies and clinics throughout the United States.
The medication contains levels of an unspecified impurity that exceeded acceptable limits during its shelf-life testing. While no injuries are reported, medications that fail impurity standards may not provide the intended therapeutic effect or could potentially lead to unexpected side effects over time.
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Packaged in Unit Dose Blister Cards of 6 (10 cards per carton). Manufactured for Mylan Pharmaceuticals Inc.
Packaged in Unit Dose Blister Cards of 6 (10 cards per carton). Manufactured for Mylan Pharmaceuticals Inc.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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