Baxter Healthcare Corporation: Pantoprazole Sodium In 0.9% Sodium Chloride Injection, 80 Mg/100 Ml (0.8 Mg/ml) Single-dose Infusion Bag In
Recall Summary Baxter Healthcare is recalling Pantoprazole Sodium 80 mg/100 mL injection in single-dose bags due to manufacturing process deviations that don't meet current good manufacturing practice (CGMP) standards. The affected product was distributed nationwide across the US, Puerto Rico, and Chile. This is classified as a Class II recall, meaning use of the product could cause adverse health effects.
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
- 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/0b7d8962-575d-4150-85f5-9a27318b81f5