# FDA recall D-0471-2017

> **Apotex Inc.** · Class III · drug recall initiated 2016-12-19.

## Product

Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida  33326, NDC 60505-3075-3.

## Reason for recall

Superpotent Drug: Product may not meet specifications throughout shelf life.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0471-2017
- **Recalling firm:** Apotex Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-19
- **Report date:** 2017-02-15
- **Termination date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2017

## Citation

> AI Analytics. FDA recall D-0471-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0471-2017. Source: US FDA. Licensed CC0.

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