Baxter Healthcare Corporation: Myxredlin, Insulin Human In 0.9% Sodium Chloride Injection, 100 Units/100 Ml (1 Unit/ml)

MYXREDLIN Recall Summary Baxter Healthcare is recalling MYXREDLIN (Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL) nationwide in the US, Puerto Rico, and Chile due to manufacturing quality control deviations. This is a Class II recall, meaning the product could cause serious health consequences but is unlikely to cause death. The recall affects the specific product with NDC number 0338-0126-12.

Recalling firm
Baxter Healthcare Corporation
Product
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.
Reason
CGMP Deviations
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-06
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide; Puerto Rico; and Chile.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/936bacb0-bd3c-4a13-9175-d76703f34698