Fresenius Kabi Compounding, Llc: Acyclovir Sodium, 200 Mg, 200mg Added To

Fresenius Kabi Compounding is recalling acyclovir sodium 200 mg intravenous injection bags nationwide because the company cannot guarantee they are sterile. The recalled product was distributed across all U.S. states and the District of Columbia. This is a Class I recall, the most serious type, indicating there is a reasonable possibility that use of the product could cause serious adverse health consequences or death.

Recalling firm
Fresenius Kabi Compounding, LLC
Product
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
Reason
Lack of Assurance of Sterility
Classification
Class I
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-02-05
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/dcedc770-84da-4d7d-b606-7f67f4182a20