Class II · Moderate risk
Aripiprazole Tablets USP
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Abilify (aripiprazole)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross Contamination with Other Products
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Affected NDC
59148-0011-13
Compare with the code on your package — it is the most precise check available.
Drug: Aripiprazole
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Abilify Aripiprazole NDC 59148-0011 |
30 mg/1 | Tablet Oral |
Otsuka America Pharmaceutical, Inc. | Rx |
- Recalling firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- NDC code
- 59148-011-13
- Origin
- N/A, Japan
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0469-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Aripiprazole recalls
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Class II · Moderate risk
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Superpotent drug
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
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Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Other recalls by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
All 2024 recalls
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
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