Amneal Fosphenytoin Sodium Injection Recall: Particulate Matter Hazard
Amneal Pharmaceuticals recalls Fosphenytoin Sodium Injection (500 mg/10 mL) made in India due to particulate matter. Affected lots and expiration dates listed. Contact for remedy.
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Presence of particulate matter
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What happened, in plain English
Amneal Pharmaceuticals is recalling Fosphenytoin Sodium Injection (500 mg/10 mL) made in India because it may contain particulate matter. This could cause serious harm if injected. Patients and healthcare providers should stop using the affected lots immediately. Read more at govinfonow.com/recall/41014-amneal-fosphenytoin-sodium-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41014-amneal-fosphenytoin-sodium-injection-recall-particulate-matter-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0610-2018
Cite this page
“Amneal Fosphenytoin Sodium Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41014-amneal-fosphenytoin-sodium-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0610-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0610-2018%22&limit=1).
Why it’s dangerous
Particulate matter in the injection can cause blockages or serious complications when administered. This is a critical risk for medical use, especially in sensitive patients.
Who’s affected
Patients and healthcare providers using the recalled Fosphenytoin Sodium Injection. Those with the specific lot numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check the lot numbers: AP160022, AP160023 (exp. 05/2018), AP16038, AP160039, AP160040 (exp. 06/2018), AP160076, AP160077, AP160078 (exp. 12/2018). The product was made in India and distributed by Amneal Biosciences.
- Brand
Amneal- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled Fosphenytoin Sodium Injection if you have the listed lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S.A Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 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-0610-2018 (December 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0610-2018 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.