Class II · Moderate risk
Acyclovir Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
acyclovir sodium
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
71506-0035-56
Compare with the code on your package — it is the most precise check available.
Drug: Acyclovir
- Recalling firm
- Fresenius Kabi Compounding, LLC
- NDC code
- 71506-035-56
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0333-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Acyclovir recalls
See all
Class II · Moderate risk
Acyclovir Sodium Injection 1
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk
Acyclovir Sodium Injection 500mg/10mL
Crystallization: customer complaints for crystallization in finished product.
Other recalls by Fresenius Kabi Compounding, LLC
All 2026 recalls
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
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