The bottle held a different drug — and why the class is still II
Bottles labelled and distributed as aripiprazole tablets 30 mg contained voriconazole tablets 50 mg instead. An antipsychotic and an antifungal were exchanged, and the classification is II.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmAjanta Pharma USA Inc
- ReasonProduct Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
- DistributionU.S. Nationwide
- Recall initiated2026-05-27
Key points
- The product is Aripiprazole Tablets USP 30 mg, 30 tablets, prescription only, NDC 27241-056-03.
- The reason is a product mix-up: a bottle of voriconazole tablets 50 mg was labelled and distributed as aripiprazole tablets USP 30 mg.
- Aripiprazole is an antipsychotic and voriconazole an antifungal, used for different purposes.
- The recalling firm is Ajanta Pharma USA Inc., the quantity 6,143 bottles, distributed nationwide.
- The recall began on 27 May 2026 and was reported on 24 June 2026, classified as II.
1An entirely different medicine inside
The previous article followed a defect in the product itself. Here there is none. The product was sound; the bottle held a different drug. Aripiprazole is an antipsychotic used in schizophrenia and bipolar disorder; voriconazole is an antifungal. They are not used for the same thing.
2A mix-up, still Class II
The question here is why this is not Class I. The record gives no reason. Set against the definitions, the assessment must have been that the health consequences reasonably expected fall within what is temporary or medically reversible, or that serious consequences are remote.
3Quantity and reach
Reaching the whole country does not make the classification heavier. The class looks at what can happen in a single instance, not at how many people might be reached. Quantity and reach are recorded in separate fields and read independently of it.
4When the label and the contents part company
Someone taking a prescribed medicine trusts what the bottle says. If the label is wrong, the correctness of the prescription and of the dispensing both lose their meaning. What this record shows is that the safety of a medicine rests not only on the quality of the product but on the identity between the package, the label and what is inside.
Why it matters
The safety of a medicine rests not only on the quality of the product but on the package, the label and the contents being the same thing. Where the label is wrong, the correctness of the prescription and of the dispensing lose their meaning. A recall class, meanwhile, turns on what can happen in a single instance and does not rise with quantity or reach, which belong to separate fields and are read on their own.
FAQ
How do aripiprazole and voriconazole differ?
Why is a mix-up still Class II?
Does a larger distribution raise the class?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0594-2026