# FDA recall D-0609-2017

> **Pfizer Inc** · Class III · drug recall initiated 2017-03-07.

## Product

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), 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 24478-190-30).

## Reason for recall

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

## Distribution

Nationwide within US

## Key facts

- **Recall number:** D-0609-2017
- **Recalling firm:** Pfizer Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-07
- **Report date:** 2017-03-29
- **Termination date:** 2019-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Peapack, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0609-2017

## Citation

> AI Analytics. FDA recall D-0609-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0609-2017. Source: US FDA. Licensed CC0.

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