FDA recall D-0441-2026

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

Distribution

Nationwide in the U.S.A.

Key facts

Status

Ongoing

Initiation date

2026-03-20

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2026