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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Quillivant XR (methylphenidate HCl) Recalled for Failed Dissolution Specifications

Agency Publication Date: September 15, 2017
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Summary

Pfizer Inc. is recalling approximately 26,502 bottles of Quillivant XR (methylphenidate HCl) extended-release oral suspension because the medication failed to meet dissolution specifications during testing. This defect means the drug may not release its active ingredient at the intended rate, which can prevent the patient from receiving the correct therapeutic dose. The recall includes 600 mg/120 mL and 750 mg/150 mL bottles distributed nationwide across the United States. Consumers should contact their healthcare provider to discuss alternative treatment options while returning affected bottles to their place of purchase.

Risk

The drug failed dissolution testing, meaning it may not break down properly in the body. This can result in the medication being less effective or providing an inconsistent dose, potentially leading to poorly managed symptoms of the condition being treated.

What You Should Do

  1. Check your medication bottles for Quillivant XR (methylphenidate HCl) extended-release oral suspension, specifically identifying the 600 mg/120 mL and 750 mg/150 mL sizes.
  2. For the 600 mg/120 mL size, check for NDC 24478-200-20 and Lot number 03216048A with an expiration date of 05/18.
  3. For the 750 mg/150 mL size, check for NDC 24478-200-25 and Lot number 03216047A with an expiration date of 02/18.
  4. If your medication matches these lot numbers and NDC codes, contact your healthcare provider or pharmacist for guidance on how to manage your treatment.
  5. Return any unused or affected medication to your pharmacy for a refund and contact Pfizer Inc. at 1-888-723-3332 (via FDA) for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance.

How to: Return any unused product to the pharmacy for a refund.

Affected Products

Product: Quillivant XR methylphenidate HCl, for extended-release oral suspension (600 mg/120 mL)
Model:
NDC 24478-200-20
Lot Numbers:
03216048A (Exp. 05/18)
Date Ranges: Expiration 05/18
Product: Quillivant XR methylphenidate HCl, for extended-release oral suspension (750 mg/150 mL)
Model:
NDC 24478-200-25
Lot Numbers:
03216047A (Exp. 02/18)
Date Ranges: Expiration 02/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77862
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (14,712 bottles; 11,790 bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.