Agency classClass IIIOur severity:Low FDA (Drugs)·D-0609-2017·Announced 2017-03-29

Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a failure to meet dissolution specifications, a quality control defect rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Pfizer Inc. is recalling 9,666 units of Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL). The affected product is distributed by NextWave Pharmaceuticals, Inc., a subsidiary of Pfizer Inc., and manufactured by Tris Pharma, Inc. The recall involves Lot # 03216025A with an expiration date of 01/18. 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 check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected product.

The recalled product

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…
Manufacturer: Pfizer Inc
Category: Drug — Prescription Medication
Hazard: dissolution-failure
Affected units: 9,666

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 #: 03216025A
Exp.01/18.

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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