X-Gen Ibuprofen Lysine Injection Recall: Particulate Matter Risk
X-Gen Pharmaceuticals recalls ibuprofen lysine injection vials due to particulate matter. This may cause serious injury if injected. Check your NDC 39822-1030-1 vials for recall.
Use caution until it’s fixed
Presence of Particulate Matter
Contact the company
What happened, in plain English
X-Gen Pharmaceuticals is recalling ibuprofen lysine injection vials that may contain particulate matter. This can cause serious injury if injected into the body. The recall affects vials with NDC 39822-1030-1. Read more at govinfonow.com/recall/42044-x-gen-ibuprofen-lysine-injection-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42044-x-gen-ibuprofen-lysine-injection-recall-particulate-matter-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0637-2017
Cite this page
“X-Gen Ibuprofen Lysine Injection Recall: Particulate Matter Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42044-x-gen-ibuprofen-lysine-injection-recall-particulate-matter-risk. Based on FDA recall #D-0637-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0637-2017%22&limit=1).
Why it’s dangerous
Particulate matter in the injection can cause serious injury when injected into the body. This risk is higher for people who need to use the medication regularly.
Who’s affected
People who have prescription ibuprofen lysine injection vials with NDC 39822-1030-1 are affected. Those who use the product for pain or inflammation are most at risk.
How to tell if you have this one
Check for vials labeled 'Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1)'. The product is packaged in 3 x 2 mL vials per carton (NDC 39822-1030-2).
- Brand
X-Gen Pharmaceuticals- Category
Drug
What to do — step by step
Check for Particulate Matter
Look for vials with NDC 39822-1030-1 that may contain particulate matter.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0637-2017 (February 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0637-2017 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.