[pending] ARIPIPRAZOLE (ARIPIPRAZOLE)
Pending LLM rewrite. Source: FDA_DRUG D-0594-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Ajanta Pharma USA Inc
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: PA00805
- expires: 01/31/2029
UPCs (6)
- 0327241051036
- 0327241055034
- 0327241053030
- 0327241056031
- 0327241054037
- 0327241052033
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ARIPIPRAZOLE
- ModeratePrescription Aripiprazole tablets recalled nationwide for storage temperature deviation
FDA (Drugs) · 2024-01-03
- HighAntipsychotic Drug Recalled for Failed Quality Control Test
FDA (Drugs) · 2023-04-26
- ModeratePrescription drug aripiprazole tablets recalled for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- ModerateAripiprazole Tablets Recalled Following FDA Inspection for Manufacturing Deviations
FDA (Drugs) · 2023-03-08
- HighAripiprazole tablets recalled due to manufacturing process deviations
FDA (Drugs) · 2023-03-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAccucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08