Drug recall: Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59
FDA enforcement event 94382 is a drug recall by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. of Tokushima, N/A, initiated 9 Apr 2024 and classified Class III, with 4 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 15% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd., Tokushima, N/A, Japan.
Reason for recall
"Cross Contamination with Other Products"
Distribution
"USA nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0466-2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 | 108,192/30 count bottles or 7 count blister packs | Class III | Ongoing | 1 May 2024 |
| D-0467-2024 | Abilify (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. | N/A | Class III | Ongoing | 1 May 2024 |
| D-0468-2024 | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 | N/A | Class III | Ongoing | 1 May 2024 |
| D-0469-2024 | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 | N/A | Class III | Ongoing | 1 May 2024 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Cross Contamination with Other Products"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "USA nationwide."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.