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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Acyclovir Sodium Injection Recalled for Particulate Matter Contamination

Agency Publication Date: October 17, 2022
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Summary

AuroMedics Pharma LLC has recalled approximately 89,400 vials of Acyclovir Sodium Injection (500mg/10mL), a generic antiviral medication used to treat infections. The recall was triggered by a customer complaint regarding dark red, brown, and black particulate matter floating inside a vial. While no injuries have been reported to date, the presence of foreign particles in an injectable drug is a serious safety concern.

Risk

Injecting a product containing particulate matter can cause local inflammation, allergic reactions, or the blockage of blood vessels. If these particles travel through the bloodstream to the lungs, heart, or brain, they could cause severe tissue damage or life-threatening events such as a stroke.

What You Should Do

  1. This recall involves Acyclovir Sodium Injection (500mg/10mL), packaged in 10 mL single-dose vials with NDC 55150-154-10. Affected units are marked with lot number AC22006 and an expiration date of 08/2023.
  2. Stop using the recalled product immediately.
  3. Contact AuroMedics Pharma LLC or your medical distributor to arrange for the return of any remaining vials from the affected lot.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Acyclovir Sodium Injection (10 mL)
Variants: 500mg/10mL (50mg/mL), Single Dose Vial
Lot Numbers:
AC22006 (Exp 08/2023)
NDC:
55150-154-10

Distributed by AuroMedics Pharma LLC; Made in India.

Product Images

Product label, Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL)

Product label, Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90896
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Sold By: Hospitals; Clinics; Healthcare Providers
Manufactured In: India, United States
Units Affected: 89400 vials
Distributed To: Nationwide
Agency Last Updated: October 18, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.