Pfizer Inc. recalls Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted
Pfizer recalls Quillivant XR methylphenidate HCl oral suspension due to failed dissolution specifications. This medication may not release properly when taken, potentially affecting effectiveness. Contact Pfizer for details.
Recall notice
Failed Dissolution Specifications
Contact the company & request your remedy
What happened, in plain English
Pf: Pfizer is recalling Quillivant XR methylphenidate HCl oral suspension because it failed dissolution specifications. This means the medication might not release properly when taken, which could affect its effectiveness. The recall applies to specific lot numbers and is for prescription-only use. Read more at govinfonow.com/recall/41410-pfizer-quillivant-xr-methylphenidate-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41410-pfizer-quillivant-xr-methylphenidate-recall-failed-dissolution-specifications · Updated October 7, 2026 · FDA enforcement record: FDA #D-1164-2017
Cite this page
“Pfizer Quillivant XR Methylphenidate Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41410-pfizer-quillivant-xr-methylphenidate-recall-failed-dissolution-specifications. Based on FDA recall #D-1164-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1164-2017%22&limit=1).
Why it’s dangerous
The medication failed dissolution specifications, meaning it may not release the active ingredient properly when taken. This could lead to inconsistent dosing and reduced effectiveness of the medication. However, the recall does not specify a risk of serious injury or harm.
Who’s affected
Prescription patients using Quillivant XR methylphenidate HCl oral suspension with the specific lot number (03216047A) are affected. Those with the medication distributed by Nextwave Pharmaceuticals, Inc. (a Pfizer subsidiary) are most at risk.
How to tell if you have this one
Check the product label for the lot number 03216047A. The medication is a prescription-only oral suspension with NDC 24478-200-25, distributed by Nextwave Pharmaceuticals, Inc. (a Pfizer subsidiary).
- Brand
Pfizer- Category
Drug
All 2 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1163-2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 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 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.; Lot # 03216048A, Exp. 05/18 | 14,712 bottles |
| D-1164-2017 | 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 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-25.; Lot # 03216047A Exp. 02/18 | 11,790 bottles |
What to do — step by step
Check Product Label
Look for the lot number 03216047A on the product label to confirm if it is recalled.
Questions people ask
Is this medication safe to use?
The recall does not indicate a safety risk; it is due to failed dissolution specifications, which may affect effectiveness but not cause injury.
What should I do if I have this medication?
Check the product label for the lot number 03216047A. If it matches, contact Pfizer for instructions.
Is there a risk of serious injury from this medication?
The recall does not mention any risk of serious injury; it is due to potential effectiveness issues.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-1164-2017 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-1164-2017 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1164-2017 (August 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1164-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.