AuroMedics Acetaminophen Injection Recall: Discoloration and pH Failure Risk
AuroMedics Pharma recalls 100mL IV acetaminophen injection vials with discoloration or failed pH tests. These vials may not be safe for medical use. Check your vials for discoloration or unusual pH levels.
Lower-risk recall
Discoloration and failed pH specifications
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What happened, in plain English
AuroMedics Pharma is recalling 100mL single-dose IV acetaminophen injection vials that may have discoloration or failed pH tests. This could mean the medication is unsafe for medical use, especially in intravenous administration. Read more at govinfonow.com/recall/36561-auromedics-acetaminophen-injection-recall-discoloration-and-ph-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36561-auromedics-acetaminophen-injection-recall-discoloration-and-ph-failure-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0248-2021
Cite this page
“AuroMedics Acetaminophen Injection Recall: Discoloration and pH Failure Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36561-auromedics-acetaminophen-injection-recall-discoloration-and-ph-failure-risk. Based on FDA recall #D-0248-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0248-2021%22&limit=1).
Why it’s dangerous
The vials may show discoloration or have failed pH specifications, which could indicate improper manufacturing. This might lead to unsafe medication if used for intravenous injections.
Who’s affected
Healthcare professionals using these vials for intravenous medication administration are affected. Patients receiving IV acetaminophen from this product are at risk if the vial is unsafe.
How to tell if you have this one
Check for discoloration or unusual color in the vial. The product was distributed by AuroMedics Pharma LLC with NDC 55150-307-01 and expired by 9/2022 or 10/2022.
- Brand
AuroMedics- Category
Drug
What to do — step by step
Check Vial Condition
Inspect the vial for discoloration or unusual color. If present, do not use.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 2.7 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-0248-2021 (December 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0248-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.