acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intrave...

FDA Recall #D-0333-2026 — Class II — February 5, 2026

Recall #D-0333-2026 Date: February 5, 2026 Classification: Class II Status: Ongoing

Product Description

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 for Recall

Lack of Assurance of Sterility

Recalling Firm

Fresenius Kabi Compounding, LLC — Canton, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1057 bags

Distribution

US Nationwide.

Code Information

Lot # C274-000049124, Exp Date: 28-Feb-26.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated