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  5. FDA Recall: Abilify

FDA Recall Abilify

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The most recent Recall Enforcement Report that covers this product was initiated on April 9th, 2024 and classified as a Class III recall due to cross contamination with other products This recall is currently ongoing, and the associated recall number is recall number is D-0466-2024. It pertains to Abilify identified by 59148-006.

Recall Number Recall Initiation Date Report Date Quantity Product Description Recall Reason Status
D-0466-202404-09-202405-01-2024108,192/30 count bottles or 7 count blister packsAbilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13Cross Contamination with Other ProductsOngoing
D-0467-202404-09-202405-01-2024N/AAbilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.Cross Contamination with Other ProductsOngoing
D-0469-202404-09-202405-01-2024N/AAbilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13Cross Contamination with Other ProductsOngoing
D-0468-202404-09-202405-01-2024N/AAbilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13Cross Contamination with Other ProductsOngoing
D-181-201311-02-201203-13-201321 blister packsABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.Terminated

What is a Recall Enforcement Report?

A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.

When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.

The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.

Understanding Recall Reports

The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.

Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.

If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.