---
title: "Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC ... — FDA record D-0367-2023 | Is It on Recall"
description: "CGMP Deviations: recalling drug products following an FDA inspection."
url: https://isitonrecall.com/recall/fda-drug-d-0367-2023-aripiprazole-tablets-usp-10-mg-rx-only-packaged-as-a-30-count-bottle-ndc-16729-280-10-upc-3-16729-28/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 10... — FDA record D-0367-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
- **Reason**: CGMP Deviations: recalling drug products following an FDA inspection.
- **Classification**: Class II
- **Recalling firm**: Accord Healthcare, Inc.
- **Quantity**: 539,004 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0367-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0367-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

United States including Puerto Rico and Canada

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Mar 8, 2023
- **Recall initiation date**: Feb 7, 2023
- **Center classification date**: Mar 2, 2023
- **Termination date**: Apr 22, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0367-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Accord Healthcare, Inc. records](https://isitonrecall.com/brand/accord-healthcare-inc/)