Amneal Fosphenytoin Sodium Injection Recall: Particulate Matter Hazard
Amneal Pharmaceuticals recalls 500 mg fosphenytoin sodium injection vials due to particulate matter. This could cause serious injury if injected. Affected vials have specific NDC and lot numbers.
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Presence of Particulate Matter
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What happened, in plain English
Amneal Pharmaceuticals is recalling 500 mg fosphenytoin sodium injection vials that may contain particulate matter. This can cause serious injury if injected into the bloodstream. The recall affects vials with specific NDC and lot numbers. Read more at govinfonow.com/recall/41286-amneal-fosphenytoin-sodium-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41286-amneal-fosphenytoin-sodium-injection-recall-particulate-matter-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0076-2018
Cite this page
“Amneal Fosphenytoin Sodium Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41286-amneal-fosphenytoin-sodium-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0076-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0076-2018%22&limit=1).
Why it’s dangerous
Particulate matter in the injection can enter the bloodstream during administration, potentially causing serious injury or death. This is a critical hazard for medications used in life-threatening conditions.
Who’s affected
Healthcare professionals who use these vials for medical treatment. Patients receiving this medication through a healthcare provider are at risk if the vial is used without proper checks.
How to tell if you have this one
Check for the NDC number 70121-1390-7 and lot number AP160016 on the vial. The vials were distributed by Amneal Biosciences and expire May 2018.
- Brand
Amne:al- Category
Drug
What to do — step by step
Stop Using Vial Now
Immediately stop using the recalled vial if you have it. Do not administer the medication.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “MS, NC, OH, TX, UT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Mississippi, North Carolina, Ohio, Texas, Utah.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0076-2018 (August 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0076-2018 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.