# FDA recall D-1163-2017

> **Pfizer Inc.** · Class III · drug recall initiated 2017-08-04.

## Product

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted,   Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1163-2017
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-04
- **Report date:** 2017-09-27
- **Termination date:** 2019-04-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1163-2017

## Citation

> AI Analytics. FDA recall D-1163-2017. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1163-2017. Source: US FDA. Licensed CC0.

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