The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0368-2023·Announced 2023-03-08

Aripiprazole 15 mg Tablets Recalled Due to Manufacturing Practice Deviations

Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) 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 classification with no reported illnesses or injuries. The recall was initiated due to Current Good Manufacturing Practice deviations identified during FDA inspection; however, no specific product harm or contamination has been confirmed. This represents a precautionary, quality-based recall without reported adverse health effects, meeting the criteria for Moderate severity.

Plain-English summary

Accord Healthcare, Inc. is recalling Aripiprazole Tablets, USP 15 mg from the U.S. market. The affected product is available in two package sizes: 30-count bottles (NDC 16729-281-10) and 100-count bottles (NDC 16729-281-01). These tablets were manufactured by Intas Pharmaceuticals Limited in India and distributed throughout the United States, Puerto Rico, and Canada. A total of 312,864 bottles are subject to this recall.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. CGMP standards ensure that pharmaceutical products are manufactured consistently and meet established quality and purity specifications.

The recall affects multiple batches with expiration dates ranging from August 31, 2023 to July 31, 2025. Patients currently taking this medication and healthcare providers should verify the batch numbers of the product in use to determine if the medication is affected.

Patients with this medication should contact their pharmacy or healthcare provider for guidance. Any adverse events or quality concerns related to this product should be reported to the FDA's MedWatch program.

The recalled product

Product
ARIPIPRAZOLE (ARIPIPRAZOLE)
Brand
ARIPIPRAZOLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Psychiatric Medication
Hazard
Affected units
312,864

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) P2004997
  • P2004998
  • P2004999
  • Exp. Date 8/31/2023
  • P2101206
  • Exp. Date 1/31/2024
  • P2102486
  • Exp. Date 4/30/2024
  • P2106247
  • P2105375
  • Exp. Date 7/31/2024
  • P2107239
  • P2107240
  • Exp. Date 10/31/2024
  • b) P2204222 Exp. Date 7/31/2025
  • P2105374 Exp. 7/31/2024
  • P2203449 Exp. 5/31/2025

UPCs (2)

  • 316729281102
  • 316729281010

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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