AuroMedics Pharma recalls Acyclovir Sodium Injection vials due to dark red, brown, and black particulate matter found in the product. This may cause injury if injected.
“AuroMedics Acyclovir Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34315-auromedics-acyclovir-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0013-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2023%22&limit=1).
AuroMedics Pharma LLC voluntarily recalled Acyclovir Sodium Injection, 500mg/10mL vials due to the presence of particulate matter, according to the FDA. The recall was announced on September 26, 2022.
How to tell if you have it
Brand: AuroMedics
Product: Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial
NDC: 55150-154-10
Lot: AC22006
Expiration: 08/2023
The hazard
The recall addresses customer complaints of dark red, brown, and black particulate floating inside the vials. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show AuroMedics Pharma LLC has issued 22 other recalls since December 4, 2017. Recent similar recalls include an AuroMedics Fondaparinux Injection recall on September 30, 2022, and a Tranexamic Acid Injection recall on September 26, 2022. Other recent recalls of similar products include an American Regent Papaverine HCl Injection recall (July 24, 2026), a Mallinckrodt Acthar Gel 5mL Vial recall (August 6, 2026), and an American Regent Nitroglycerin Injection recall (July 24, 2026).
How to tell if you have this one
Check for vials labeled 'Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only'. The product was distributed by AuroMedics Pharma LLC in the US and made in India with NDC 55150-154-10.
Brand
AuroMedics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Contents
Inspect the vial for dark red, brown, or black particles floating inside.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0013-2023 (September 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0013-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.