FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter MYXREDLIN insulin injection recalled for CGMP manufacturing deviations
What this means
Baxter Healthcare is recalling specific lots of MYXREDLIN (insulin human injection) due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lots were distributed in the US, Puerto Rico, and Chile. No injuries have been reported.
- Check if your insulin matches one of the recalled lot numbers (NC188630, NC188708, NC188791, NC188845, NC188876, NC188968, NC193719, NC193849, NC194051, NC194105, or NC195171)
- Contact your pharmacy or healthcare provider if you have an affected lot
- Do not stop using insulin without medical guidance; ask your provider about an alternative
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0806-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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