FDA recall D-0335-2026

Product

thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-02-05

Report date

2026-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2026