FDA recall D-0429-2026

Fresenius Kabi USA, LLC · Class II · drug

Product

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide , Alaska, and Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2026-03-11
Report date
2026-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2026