FDA-Drug2026-09-09Class IIPROCESSING DEFECT

Baxter MYXREDLIN insulin injection recalled for CGMP manufacturing deviations

OTHERNationwide distributionDrugs

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-0806-2026

More Baxter recalls

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