Pfizer PROTONIX I.V. Recall: Subpotent Drug Risk
Pfizer recalls PROTONIX I.V. (pantoprazole sodium) for injection due to potency issues at 6-month stability. This may affect drug effectiveness. Check your vial lot numbers for recall.
Lower-risk recall
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Contact the company
What happened, in plain English
Pfizer is recalling PROTONIX I.V. injections because some batches have lower-than-stated drug potency. This could mean the medication isn't as effective as it should be over time, potentially leading to treatment issues. Read more at govinfonow.com/recall/42146-pfizer-protonix-i-v-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42146-pfizer-protonix-i-v-recall-subpotent-drug-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0516-2017
Cite this page
“Pfizer PROTONIX I.V. Recall: Subpotent Drug Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42146-pfizer-protonix-i-v-recall-subpotent-drug-risk. Based on FDA recall #D-0516-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0516-2017%22&limit=1).
Why it’s dangerous
The drug may not be as potent as labeled after 6 months of storage. This could reduce effectiveness in treating conditions like acid reflux or ulcers, but does not cause immediate harm or injury.
Who’s affected
Patients receiving PROTONIX I.V. injections for conditions like acid reflux or ulcers. Those with specific lot numbers from the recall list are most at risk.
How to tell if you have this one
Check your PROTONIX I.V. vial lot numbers: A) 325449 (exp 12/16), N97969 (exp 03/17), N69175 (exp 03/17), N69177 (exp 03/17), N95727 (exp 04/17); B) M51076 (exp 11/16); C) 317364 (exp 11/16), N73763 (exp 03/17).
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Vial Lot Numbers
Look for specific lot numbers on the vial packaging: A) 325449 (exp 12/16), N97969 (exp 03/17), etc.; B) M51076 (exp 11/16); C) 317364 (exp 11/16), N73763 (exp 03/17).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0516-2017 (November 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0516-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.