Aurobindo Pharma USA Inc. has recalled approximately 20,869 bottles of Olanzapine tablets, a prescription medication used to treat certain mental/mood conditions. The recall affects 2.5 mg and 7.5 mg tablets (30-count bottles) manufactured for Prasco Laboratories. The recall was initiated because the product failed to meet stability specifications for impurities and degradation, which means the medication may contain higher-than-approved levels of breakdown products. Consumers should consult their healthcare provider to discuss their treatment options and obtain a replacement prescription if necessary.
The medication failed to meet quality standards for impurities and degradation over time, which may lead to reduced drug effectiveness or unexpected exposure to chemical breakdown products.
Healthcare consultation and pharmacy refund
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Sources: FDA iRES · Raw API Response
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