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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Pharmaceuticals (USA) Inc: Acyclovir Sodium Injection Recalled for Product Crystallization

Agency Publication Date: March 30, 2021
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Summary

Zydus Pharmaceuticals is recalling approximately 2,454 packs of Acyclovir Sodium Injection (500mg/10mL and 1000mg/20mL) because crystals have formed inside the finished product. Acyclovir is an antiviral drug used to treat infections caused by herpes viruses, and these specific lots are administered by intravenous infusion. The defect was discovered following customer complaints of crystallization in the vials. You should check your medication for the specific lot numbers and expiration dates listed below and consult your doctor if you have this product.

Risk

Injecting a product containing crystals can cause serious health problems, such as inflammation or blockages in the blood vessels, which could lead to organ damage or other life-threatening complications.

What You Should Do

  1. Check your Acyclovir Sodium Injection vials for the following identifying information: NDC 68382-049-10 (1000mg/20mL) with lot L000155 (Exp 12/2021) or lot L000156 (Exp 1/2022).
  2. Check your Acyclovir Sodium Injection vials for NDC 68382-048-10 (500mg/10mL) with lot L000126 or lot L000127 (both Exp 12/31/2021).
  3. Immediately stop using any vials from the affected lots and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  4. Return any unused vials from these lots to the place of purchase or pharmacy for a refund.
  5. Contact Zydus Pharmaceuticals (USA) Inc. at their Pennington, New Jersey office for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Acyclovir Sodium Injection 1000mg/20mL (50mg/mL)
Model:
NDC 68382-049-01
NDC 68382-049-10
Lot Numbers:
L000155 (Exp 12/2021)
L000156 (Exp 1/2022)
Date Ranges: Expiration 12/2021, Expiration 01/2022
Product: Acyclovir Sodium Injection 500mg/10mL (50mg/mL)
Model:
NDC 68382-048-01
NDC 68382-048-10
Lot Numbers:
L000126 (Exp 12/31/2021)
L000127 (Exp 12/31/2021)
Date Ranges: Expiration 12/31/2021

Product Images

Acyclovir Sodium Injection, 500 mg/10mL vial

Acyclovir Sodium Injection, 500 mg/10mL vial

Acyclovir Sodium Injection, 1000 mg/20mL vial

Acyclovir Sodium Injection, 1000 mg/20mL vial

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87364
Status: Resolved
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: hospitals; clinics; pharmacies
Manufactured In: India, United States
Units Affected: 2 products (816 packs; 1,638 packs)
Distributed To: Nationwide
Agency Last Updated: April 7, 2021

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.

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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.