Pfizer Quillivant XR 750mg/150mL Recall: Failed Dissolution Specifications
Pfizer recalls Quillivant XR (methylphenidate) oral suspension due to failed dissolution testing at 12 months. This medication is prescription-only and distributed by NextWave Pharmaceuticals.
Lower-risk recall
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Contact the company
What happened, in plain English
Pfizer has recalled a specific prescription version of Quillivant XR (methylphenidate) because it failed dissolution testing at 12 months. This means the medication may not release the active ingredient properly over time, potentially affecting its effectiveness. Read more at govinfonow.com/recall/41827-pfizer-quillivant-xr-750mg-150ml-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41827-pfizer-quillivant-xr-750mg-150ml-recall-failed-dissolution-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0608-2017
Cite this page
“Pfizer Quillivant XR 750mg/150mL Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41827-pfizer-quillivant-xr-750mg-150ml-recall-failed-dissolution-specifications. Based on FDA recall #D-0608-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2017%22&limit=1).
Why it’s dangerous
The medication failed dissolution testing at 12 months, meaning it may not release the active ingredient (methylphenidate) properly over time. This could affect how well the medication works for ADHD treatment.
Who’s affected
Prescription patients using Quillivant XR 750mg/150mL (25mg/5mL) for ADHD. Those with the specific lot number 03216026A are most at risk.
How to tell if you have this one
Check your prescription label for Quillivant XR (methylphenidate HCl) 750mg/150mL (25mg/5mL). Look for lot number 03216026A on the container.
- Brand
Pfizer- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide within US
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0607-2017 | 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 24478-190-10).; Lot #: 03215042A, Exp. 08/17. | 28,938 units |
| D-0608-2017 | 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 24478-205-25).; Lot #: 03216026A, Exp. 02/18 | 11,862 units |
| D-0609-2017 | 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).; Lot #: 03216025A, Exp.01/18. | 9,666 units |
What to do — step by step
Check Your Medication
Verify the product label matches Quillivant XR 750mg/150mL (25mg/5mL) with lot number 03216026A.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this medication safe to use?
The recall is due to failed dissolution testing at 12 months, not immediate safety risks. It may affect effectiveness but not cause harm directly.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0608-2017 (March 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0608-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.