The Harvard Drug Group LLC is recalling 2,238 cartons of Omega-3-Acid Ethyl Esters Capsules (1 gram), which is the generic version of the heart medication Lovaza. The recall was initiated after routine stability testing found the capsule shells were losing moisture at a rate that failed quality specifications. This quality issue may affect the integrity of the medication's packaging and stability, though no injuries or adverse events have been reported to date. These prescription capsules were sold nationwide in 50-count unit dose cartons under the Major Pharmaceuticals brand.
The capsule shells failed quality testing for 'Loss on Drying,' which can compromise the physical integrity of the capsules and potentially affect how the medication is absorbed or maintained over its shelf life.
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Recall #: D-0493-2026
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Sources: FDA iRES · Raw API Response
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