Amneal Pharmaceuticals has recalled 4,309 bottles of Divalproex Sodium Extended Release Tablets, 250 mg, which is the generic version of the medication Depakote. The recall was initiated because the tablets failed dissolution testing, meaning they may not release the medication into the body at the correct rate. These tablets are used to treat certain types of seizures, bipolar disorder, and to prevent migraine headaches. No incidents or injuries have been reported to date.
If the tablets do not dissolve properly, the medication may not be absorbed correctly, which could lead to a loss of seizure control or a return of symptoms for patients with bipolar disorder or migraines. This poses a potential risk of therapeutic failure.
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Recall #: D-1362-2022. Manufactured by Amneal Pharmaceuticals, India; Distributed by Amneal Pharmaceuticals, Bridgewater, NJ.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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 ยท Raw API Response
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