Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure
Pfizer is recalling Quillivant XR extended-release oral suspension due to failed 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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Pfizer Inc is recalling Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL). The recall involves 11,862 units of Lot 03216026A with an expiration date of 02/18. The product was distributed nationwide within the US.
The recall was initiated because the product failed dissolution specifications. Specifically, the dissolution at 8 hours was out of specification at 12 months when stored at 25 degrees Celsius.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on alternatives or returns.
The recalled product
- Product
- Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 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
- Affected units
- 11,862
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 #: 03216026A
- Exp. 02/18
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.
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