Prescription Aripiprazole tablets recalled nationwide for storage temperature deviation
Cardinal Healthcare is recalling Aripiprazole 5 mg tablets nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with CGMP storage deviation; no reported illnesses or injuries and no confirmed product harm; the hazard is theoretical rather than confirmed damage.
Plain-English summary
Cardinal Healthcare initiated a nationwide recall of Aripiprazole 5 mg tablets (NDC 65162-897-03, Batch AR202318) distributed by Amneal Pharmaceuticals LLC. The recall was triggered by Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing quality controls.
The deviation involved exposure of products to temperatures outside the labeled storage conditions. This storage condition deviation occurred during the production process.
No illnesses or injuries have been reported in connection with this recall. Patients currently taking the affected batch should contact their healthcare provider or pharmacist. Do not discontinue use without consulting your healthcare provider first.
Consumers with questions about whether they have affected product should verify the batch number (AR202318) on their prescription bottle. Those with the recalled batch or who experience any adverse effects should report concerns to the FDA MedWatch program or their healthcare provider.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Antipsychotic
- Affected units
- 2
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 (1)
- Batch AR202318
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
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