← FDA ENFORCEMENT
D-0808-2026Class II

Baxter Healthcare Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2026-09-09
Distribution
US Nationwide; Puerto Rico; and Chile.
Firm state
IL
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.

Code / lot info

Lot # NC193764, Exp Date: 10/18/2027; Lot # NC195232, Exp Date: 11/25/2027.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →