Baxter Recalls MYXREDLIN Insulin Due to Manufacturing Deviations
Baxter Healthcare is voluntarily recalling MYXREDLIN insulin due to CGMP deviations. The recall covers specific lots distributed in the US, Puerto Rico, and Chile.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of MYXREDLIN (Insulin Human in 0.9% Sodium Chloride Injection). The recall was initiated on August 6, 2026, and is classified as Class II by the FDA. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.
The affected product is MYXREDLIN, 100 units/100 mL (1 unit/mL), NDC 0338-0126-12. The specific lots involved are NC188630, NC188708, NC188791, NC188845, NC188876, NC188968 (Exp 12/31/2027); NC193719, NC193849 (Exp 04/30/2028); NC194051, NC194105 (Exp 05/31/2028); and NC195171 (Exp 06/30/2028). These products were distributed nationwide in the United States, as well as in Puerto Rico and Chile.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- MYXREDLIN (INSULIN HUMAN)
- Brand
- MYXREDLIN
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Insulin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot # NC188630
- NC188708
- NC188791
- NC188845
- NC188876
- NC188968
- Exp Date: 12/31/2027
- Lot # NC193719
- NC193849
- Exp Date: 04/30/2028
- Lot # NC194051
- NC194105
- Exp Date: 05/31/2028
- Lot # NC195171
- Exp Date: 06/30/2028.
Distribution
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