Aripiprazole Tablets Recalled Following FDA Inspection for Manufacturing Deviations
Accord Healthcare recalls 539,004 bottles of Aripiprazole 10 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing process deviations found during an FDA inspection.
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 no reported illnesses or injuries. CGMP deviations represent manufacturing process compliance issues without an identified specific product hazard. The recall appears precautionary.
Plain-English summary
Accord Healthcare, Inc. is recalling Aripiprazole Tablets, USP 10 mg, packaged in 30-count and 100-count bottles, due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA facility inspection. The recalled product was distributed throughout the United States, Puerto Rico, and Canada.
The recall affects 539,004 bottles manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare. Affected batches include P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944 (expiring 8/31/2023); P2107593, P2106907, P2106906, P2106908, P2106909 (expiring 10/31/2024); P2102144 (expiring 3/31/2023); P2106903 (expiring 10/31/2023); and P2204437 (expiring 7/31/2025).
Patients taking this medication should contact their healthcare provider to discuss whether they have a recalled batch and determine appropriate next steps. Do not stop taking the medication without medical guidance, as abruptly discontinuing an antipsychotic can cause adverse health effects. Consumers may also report any side effects to the FDA through MedWatch.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Antipsychotic Medication
- Affected units
- 539,004
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 (20)
- Batches: a)P2006421
- P2004882
- P2004939
- P2004883
- P2004940
- P2004942
- P2004943
- P2004944
- Exp. Date 8/31/2023
- P2107593
- P2106907
- P2106906
- P2106908
- P2106909
- Exp. Date 10/31/2024
- b)P2102144
- Exp. Date 3/31/2023
- P2106903 Exp. Date 10/31/2023
- P2204437
- Exp. Date 7/31/2025
UPCs (2)
- 316729280105
- 316729280013
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. 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.
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