Ascend Laboratories, LLC recalls 2,256 bottles of ARIPIPRAZOLE 10 mg tablets distributed nationwide after discovering the product to be superpotent. The recall involves ARIPIPRAZOLE tablets manufactured by Alken Laboratories Ltd. in India and distributed in the United States. The recall date is August 28, 2025, with consumer notification by letter and guidance to stop use.
Superpotent drug
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
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ARIPIPRAZOLE is an antipsychotic medication used to treat conditions like schizophrenia and bipolar disorder. The 10 mg tablet is a common dosage form.
Superpotent drug increases risk of overdose or adverse reactions if administered at normal dosages. Precise potency differential is not detailed in the recall notice.
This recall is not indicated as part of a broader industry pattern.
Consumers may experience overdose symptoms or unexpected reactions if exposed to the superpotent lot; immediate cessation is advised.
NDC and lot numbers are on the product label and packaging.
Recall notification letters will guide refunds or replacements; processing typically weeks.
Keep the recall letter, receipts, and any medical records in case of audit or claim.
Aripiprazole Tablets, USP, 10 mg, 30-count bottles. Manufactured by Alken Laboratories Ltd., INDIA. Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC 67877-432-03. Quantity: 2,256 bottles. Lot #: 24144162. Expiration: 09/2027. Sold nationwide in the USA.
No specific injuries or incidents are documented in the recall notice. The status is ACTIVE with a HIGH hazard level.
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