FDA Recall D-0441-2026
Fagron Compounding Services · Wichita, KS
Class II Ongoing 55 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Reason for recall
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall record
- Recall number
D-0441-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the U.S.A.
- Recall initiated
- 2026-03-20
- Classified by FDA Center
- 2026-04-07
- FDA published
- 2026-04-15
- Recalling firm
- Fagron Compounding Services
- Firm location
- Wichita, KS
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.