# FDA recall D-1285-2022

> **Apotex Corp.** · Class II · drug recall initiated 2022-07-07.

## Product

Aripiprazole Tablets, USP 20 mg,  packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

## Reason for recall

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-1285-2022
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-07
- **Report date:** 2022-07-27
- **Termination date:** 2025-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1285-2022

## Citation

> AI Analytics. FDA recall D-1285-2022. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-1285-2022. Source: US FDA. Licensed CC0.

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