Baxter Healthcare Corporation: Pantoprazole Sodium In 0.9% Sodium Chloride Injection, 80 Mg/100 Ml (0.8 Mg/ml) Single-dose Infusion Bag In
Baxter Healthcare is recalling Pantoprazole Sodium 80 mg/100 mL injection bags used to treat stomach acid conditions because the product was manufactured with deviations from required quality and safety standards. The recalled medication was distributed nationwide across the US, Puerto Rico, and Chile. This is a Class II recall, meaning the product could cause adverse health effects but is unlikely to cause serious injury.
- 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/375fd264-b43a-4087-b3b8-94ef113c2cbd