# FDA recall D-0114-2021

> **The Harvard Drug Group** · Class II · drug recall initiated 2020-11-18.

## Product

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04

## Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0114-2021
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-11-18
- **Report date:** 2020-12-09
- **Termination date:** 2023-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0114-2021

## Citation

> AI Analytics. FDA recall D-0114-2021. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/D-0114-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*