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Drug recall · FDA · Published March 7, 2017

Pfizer Inc recalls Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only,

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

🇺🇸 FDA recall #D-0608-2017DrugPFIZER INC ›
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Recalling firmPfizer Inc100 North Route 206 · Peapack, NJ 07977
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/41827-pfizer-inc-recalls-quillivant-xr-methylphenidate-hcl-for-extended-release · Recall date March 7, 2017 · FDA enforcement record: FDA #D-0608-2017

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“Pfizer Inc recalls Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only,.” GovInfoNow, recall dated March 7, 2017. https://govinfonow.com/recall/41827-pfizer-inc-recalls-quillivant-xr-methylphenidate-hcl-for-extended-release. Based on FDA recall #D-0608-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2017%22&limit=1).

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  • Brand
    PFIZER INC
  • Category
    Drug
FDA recall event · 3 products

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 numberProduct, codes & lotsQuantity
D-0607-2017Quillivant 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-0608-2017Quillivant 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. 02/1811,862 units
D-0609-2017Quillivant 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
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Contact PFIZER INC

We’ve drafted a message you can send PFIZER INC to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-0608-2017 — PFIZER INC Pfizer Inc recalls Quillivant XR (methylphenidate HCl) for extended-release oral suspens

Hello,

I own a Pfizer Inc recalls Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, that is covered by recall D-0608-2017 from PFIZER INC.

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.

Similar recalls

Pfizer Inc. recalls Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted
Pfizer · 93% matchPfizer Inc. recalls Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of
PFIZER INC · 85% matchNovartis Pharmaceuticals Corp. recalls Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville
Novartis Pharmaceuticals Corp. · 83% matchPfizer Inc. recalls Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each
Pfizer · 82% matchPfizer Inc. recalls Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28
PFIZER INC · 82% match

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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.
  • 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA