Pantoprazole Sodium in 0.9% Chloride Injection recall
FDA recall D-0812-2026 · initiated Aug 6, 2026
Baxter Healthcare Corporation recalled Pantoprazole Sodium in 0.9% Chloride Injection in Aug 2026 — an FDA Class II recall (D-0812-2026) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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.
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Initiated
- Aug 6, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Pantoprazole Sodium in 0.9% Chloride Injection recalled?
- Baxter Healthcare Corporation recalled Pantoprazole Sodium in 0.9% Chloride Injection in Aug 2026 — an FDA Class II recall (D-0812-2026) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Pantoprazole Sodium in 0.9% Chloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0812-2026 was: CGMP Deviations
- Is a recalled Pantoprazole Sodium in 0.9% Chloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pantoprazole Sodium in 0.9% Chloride Injection are affected?
- Distributed: US Nationwide; Puerto Rico; and Chile.. The recall covers these lots — Lot # NC194129, Exp Date: 05/07/2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0812-2026.