The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0369-2023·Announced 2023-03-08

Aripiprazole 20 mg Tablets Recalled for Manufacturing Quality Deviations

Accord Healthcare is recalling 170,448 bottles of Aripiprazole 20 mg tablets distributed in the United States, Puerto Rico, and Canada due to manufacturing quality control (CGMP) deviations identified during 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 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: This is an FDA Class II recall for a prescription medication due to manufacturing and quality control deviations. No illnesses or injuries have been reported. Per the rubric, Class II recalls with no reported harm but representing potential risk-of-harm to patients qualify as 'High' (score 3).

Plain-English summary

Accord Healthcare, Inc. is recalling 170,448 bottles of Aripiprazole Tablets, USP 20 mg, distributed throughout the United States, including Puerto Rico and Canada. The affected product is a generic antipsychotic available in 30-count bottles (NDC 16729-282-10) and 100-count bottles (NDC 16729-282-01).

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. CGMP deviations indicate that the manufacturing, processing, or quality control procedures did not meet federal regulatory standards.

Multiple batch codes are affected, with expiration dates ranging from January 2024 through August 2025.

The recalled product

Product
ARIPIPRAZOLE (ARIPIPRAZOLE)
Brand
ARIPIPRAZOLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Antipsychotic
Hazard
Affected units
170,448

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 (14)

  • Batches: a) P2100787
  • P2100788
  • Exp. Date 1/31/2024
  • P2104736
  • Exp. Date 6/30/2024
  • P2105492
  • Exp. Date 8/31/2024
  • P2107172
  • P2107175
  • Exp. Date 10/31/2024
  • P2203043
  • Exp. Date 5/31/2025
  • b) P2104086 Exp. Date 6/30/2024
  • P2205370 Exp. 8/31/2025

UPCs (2)

  • 316729282109
  • 316729282017

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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