The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0370-2023·Announced 2023-03-08

Prescription drug aripiprazole tablets recalled for manufacturing practice deviations

Accord Healthcare is recalling aripiprazole tablets (30 mg) due to manufacturing practice deviations found during an FDA inspection. The recall covers 88,728 bottles distributed to the United States, Puerto Rico, and Canada.

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: This is an FDA Class II recall initiated due to manufacturing practice deviations identified during FDA inspection, with no reported illnesses or injuries. The recall is precautionary in nature, based on compliance violations rather than direct patient harm.

Plain-English summary

Accord Healthcare, Inc. is recalling Aripiprazole Tablets, USP 30 mg distributed under the brand ARIPIPRAZOLE. The recall includes 88,728 bottles in both 30-count and 100-count package sizes distributed to the United States, including Puerto Rico and Canada.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. This is a Class II recall.

Consumers who have obtained affected bottles should consult their healthcare provider or pharmacist regarding the recall. Specific batch codes and expiration dates are provided in the official FDA recall notice to help identify affected medication.

The recalled product

Product
ARIPIPRAZOLE (ARIPIPRAZOLE)
Brand
ARIPIPRAZOLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Antipsychotic
Hazard
Affected units
88,728

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 (17)

  • Batches: a) P2005477
  • Exp. Date 9/30/2023
  • P2100002
  • Exp. Date 12/31/2023
  • P2101359 Exp. Date 2/28/2024
  • P2105409
  • Exp. Date 7/31/2024
  • P2107447
  • Exp. Date 10/31/2024
  • P2203388 Exp. Date 5/31/2025
  • b) P2101859 Exp. Date 2/28/2023
  • P2107056
  • Exp. Date 10/31/2023
  • P2203066
  • Exp. Date 5/31/2024
  • P2206130
  • Exp. Date 8/31/2024

UPCs (2)

  • 316729283106
  • 316729283014

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.

See all 67 products in this recall →

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