AuroMedics Pharma LLC recalls Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured
AuroMedics Pharma recalls 3g vials of Ampicillin/Sulbactam injections due to reported red rubber particles. Stop using if you have these specific lots.
Stop using this now
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Contact the company & request your remedy
What happened, in plain English
AuroMedics Pharma recalled 3g vials of Ampicillin and Sulbactam injections after reports of red rubber particles. This could cause serious injury if injected. Read more at govinfonow.com/recall/40580-auromedics-ampicillin-sulb-red-rubber-particles-risk-in-injections.
Source Summary by GovInfoNow · govinfonow.com/recall/40580-auromedics-ampicillin-sulb-red-rubber-particles-risk-in-injections · Updated October 7, 2026 · FDA enforcement record: FDA #D-0866-2018
Cite this page
“AuroMedics Ampicillin/Sulb: Red rubber particles risk in injections.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40580-auromedics-ampicillin-sulb-red-rubber-particles-risk-in-injections. Based on FDA recall #D-0866-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2018%22&limit=1).
Why it’s dangerous
The injections contain visible red rubber particles from the manufacturing process. If injected, these particles could cause serious injury or death.
Who’s affected
People who received the recalled vials (lots AS0317035-A and AS0317041-A) for medical use. Patients and healthcare providers using these injections are most at risk.
How to tell if you have this one
Check your vial label for the lot numbers AS0317035-A or AS0317041-A. The product was manufactured for intramuscular or intravenous use and expires August 2019.
- Brand
AuroMedics- Category
Drug
What to do — step by step
Stop Using Immediately
Discard the vial if you have the recalled lot numbers AS0317035-A or AS0317041-A.
Questions people ask
Why was this product recalled?
The recall was due to confirmed reports of red rubber particles in the injections, which could cause serious injury if injected.
What should I do if I have this product?
Discard the vial immediately if you have the recalled lot numbers AS0317035-A or AS0317041-A.
Is there a replacement available?
The recall record does not mention any replacement or alternative products.
Contact AuroMedics
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-0866-2018 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-0866-2018 from AuroMedics. 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.
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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-0866-2018 (May 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0866-2018 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.