Accord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling approximately 1.1 million bottles of Aripiprazole 5mg tablets due to Good Manufacturing Practice deviations identified during an FDA inspection. No illnesses or injuries 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 3/5 (High).
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: FDA Class II recall triggered by CGMP deviations on a prescription psychiatric medication. Manufacturing process violations represent a risk of harm to medication quality and safety. No illnesses or injuries reported, limiting the score to 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Accord Healthcare, Inc. is recalling Aripiprazole Tablets, USP 5 mg distributed in the United States, Puerto Rico, and Canada. The recall involves approximately 1,109,904 bottles across multiple affected batches.
The recall was initiated following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP) standards. These manufacturing process violations could potentially affect the quality and safety of the medication.
No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Accord Healthcare, Inc.
- Affected units
- 1,109,904
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) P2004259
- P2004260
- P2004261
- Exp. Date 7/31/2023
- P2006799
- P2101391
- Exp. Date 11/30/2023
- P2100826
- Exp. Date 1/31/2024
- P2101320
- Exp. Date 2/28/2024
- P2102510
- P2102409
- P2102407
- Exp. Date 3/31/2024
- P2102410
- P2105251
- P2105252
- P2105253
- Exp. Date 7/31/2024
UPCs (2)
- 316729279109
- 316729279017
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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