FDA Recall D-0333-2026
Fresenius Kabi Compounding, LLC · Canton, MA
Class II Ongoing 98 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0333-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2026-02-05
- Classified by FDA Center
- 2026-02-13
- FDA published
- 2026-02-18
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Firm location
- Canton, MA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.