AuroMedics Linezolid Injection Recall: Mold Particulate Risk
AuroMedics Pharma recalls Linezolid injection bags with mold particulate matter found in one batch. Stop using affected products immediately to avoid potential health risks.
Lower-risk recall
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Contact the company
What happened, in plain English
AuroMedics Pharma recalled Linezolid injection bags that contained mold particles. This could pose a health risk if the product is used as intended. Read more at govinfonow.com/recall/41005-auromedics-linezolid-injection-recall-mold-particulate-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41005-auromedics-linezolid-injection-recall-mold-particulate-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0337-2018
Cite this page
“AuroMedics Linezolid Injection Recall: Mold Particulate Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41005-auromedics-linezolid-injection-recall-mold-particulate-risk. Based on FDA recall #D-0337-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0337-2018%22&limit=1).
Why it’s dangerous
Mold particles were found in one bag during testing. This could potentially cause health issues if the product is administered.
Who’s affected
Patients receiving Linezolid injections from the recalled batch. Healthcare providers using the affected products are at risk.
How to tell if you have this one
Check for the product name 'Linezolid Injection 600 mg/300 mL (2 mg/mL)' in foil laminate overwrap bags. The batch number CLZ160007 was manufactured in India with an expiration date of August 2018.
- Brand
AuroMedics- Category
Drug
What to do — step by step
Check Product Details
Identify the product by name, batch number, and expiration date as listed in the recall notice.
How this recall unfolded
Recall timeline
FDA terminated this recall 18 months 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-0337-2018 (December 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0337-2018 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.