The FDA enforcement report lists an ongoing Class II recall, dated 9 September 2026, of pantoprazole 80 mg in 100 mL sodium chloride infusion bags from Baxter Healthcare, for deviations from current good manufacturing practice.
A Class II recall indicates the FDA considers that use may cause temporary or medically reversible harm, or that serious harm is unlikely. No clinical problem is described, and whether affected lots reached India is not stated.
- The recall concerns one premixed pantoprazole product, not pantoprazole itself.
- Pharmacies holding imported premixed bags should check lots against the FDA notice.
- Pantoprazole reconstituted from vials is unaffected.
- No action is needed for patients already treated.
Why it matters
Intravenous PPIs are used in upper GI bleeding, so a supply gap needs a ready alternative.
Don't overread it
A manufacturing-practice recall is not a finding that the drug is unsafe.
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