The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1164-2017·Announced 2017-09-27

Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure

Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

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.

Plain-English summary

Pfizer Inc. is recalling 11,790 bottles of Quillivant XR methylphenidate HCl, for extended-release oral suspension. The affected product is distributed by Nextwave Pharmaceuticals, Inc., a subsidiary of Pfizer Inc., and manufactured by Tris Pharma, Inc. The specific lot number is 03216047A with an expiration date of 02/18.

The recall was initiated because the product failed dissolution specifications. This means the medication may not release the active ingredient at the intended rate, potentially affecting its therapeutic performance. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 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…
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
11,790

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 (1)

  • Lot # 03216047A Exp. 02/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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