Baxter Healthcare Corporation: Myxredlin, Insulin Human In 0.9% Sodium Chloride Injection, 100 Units/100 Ml (1 Unit/ml)
Recall Summary Baxter Healthcare is recalling MYXREDLIN (insulin human injection) nationwide due to manufacturing process deviations that don't meet FDA standards. The recall affects the 100 units/100 mL vial (NDC 0338-0126-12) distributed across all U.S. states, Puerto Rico, and Chile. This is a Class II recall, meaning the product could cause serious adverse health effects or death.
- 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/73cc9e3c-4812-46a5-b905-e6a210814c4b