CLASS I Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Ibuprofen Lysine Injection, 20 mg/ (10 mg/mL) Single-Dose Vial recalled
X-Gen Pharmaceuticals is recalling Ibuprofen Lysine Injection, 20 mg/ (10 mg/mL) Single-Dose Vial (, distributed nationwide in the US. The recall was initiated on 8 Feb 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0637-2017
- FDA event ID
- 76410
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Brand
- Ibuprofen Lysine
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Feb 2017
- FDA classified
- 5 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 8 Feb 2017 | Recall initiated by company | |
| 5 Apr 2017 | Classified by FDA | +56 days |
| 12 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
PLND1613, Exp 02/18
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X-Gen Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | Cyclophosphamide for Injection, USP, 500mg/vial recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
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| Drug | CLASS II | Neomycin Sulfate Tablets, USP 500mg recalled by X-Gen Pharmaceuticals | X-Gen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Levetiracetam Injection, 500 mg/-use vials recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Clonidine HCL Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine | X-Gen Pharmaceuticals | Other | Nationwide |