Agency classClass IIIOur severity:Low FDA (Drugs)·D-0607-2017·Announced 2017-03-29

Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues without reported harm.

Plain-English summary

Pfizer Inc is recalling Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only. The product is distributed by NextWave Pharmaceuticals, Inc., a subsidiary of Pfizer Inc, and manufactured by Tris Pharma, Inc. The recall involves 28,938 units of the medication, specifically Lot # 03215042A with an expiration date of 08/17. The product was distributed nationwide within the US.

The recall was initiated because the product failed to meet dissolution specifications. Specifically, the dissolution at 8 hours was out of specification at 12 months when stored at 25 degrees Celsius. This indicates that the medication may not release the active ingredient as intended over time.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment. The FDA has classified this recall as Class III, which means the product is not likely to cause adverse health consequences.

The recalled product

Product: Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 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…
Manufacturer: Pfizer Inc
Category: Drug — Prescription Medication
Hazard: dissolution-failure
Affected units: 28,938

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 03215042A
Exp. 08/17.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Pfizer Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Pfizer Inc

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Same hazard · dissolution failure