The Harvard Drug Group is recalling approximately 446 cartons of Quetiapine Fumarate Extended-Release Tablets (generic Seroquel XR) in 50 mg, 150 mg, 200 mg, and 300 mg strengths. The medication was packaged with the incorrect package insert, containing instructions for the immediate-release version of the drug instead of the extended-release version. Consumers should be aware that extended-release and immediate-release medications have different dosing schedules and safety profiles.
Using the wrong instructions for an extended-release medication could lead to incorrect dosing or administration. This poses a risk of either receiving too much medication at once or not maintaining the correct levels of the drug in the bloodstream, which may affect the management of the underlying condition or increase the risk of side effects.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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