← FDA ENFORCEMENT
D-0819-2026Class 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

Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.

Code / lot info

Lot # NC185448, Exp Date: 8/31/2027; Lot # NC192910, Exp Date: 4/30/2028; Lot # NC195218, Exp Date: 6/30/2028.

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 →