Pfizer Deferoxamine Mesylate Injection Recall: Color Change Impurity Risk
Pfizer recalls Deferoxamine Mesylate injection vials due to color change impurity during manufacturing. Affected lots may pose safety risks; contact Pfizer for details.
Recall notice
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Contact the company
What happened, in plain English
Pfizer is recalling Deferoxamine Mesylate injection vials that may have color changes due to manufacturing impurities. This could affect patient safety during medical treatment. Read more at govinfonow.com/recall/41509-pfizer-deferoxamine-mesylate-injection-recall-color-change-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41509-pfizer-deferoxamine-mesylate-injection-recall-color-change-impurity-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0001-2018
Cite this page
“Pfizer Deferoxamine Mesylate Injection Recall: Color Change Impurity Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41509-pfizer-deferoxamine-mesylate-injection-recall-color-change-impurity-risk. Based on FDA recall #D-0001-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2018%22&limit=1).
Why it’s dangerous
The product was manufactured with an impurity that causes color changes during production. This impurity could potentially affect the safety of the medication when administered to patients.
Who’s affected
Patients prescribed Deferoxamine Mesylate injections are affected. Healthcare providers using the product for medical treatment are at risk.
How to tell if you have this one
Check for vials labeled 'Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial' with lot number 51275DD and expiration date 09/01/17.
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the vial to confirm if it is affected.
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 3 years 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.
Questions people ask
Is this product safe to use?
The recall is due to a manufacturing impurity that may cause color changes. The product is not safe for use until the recall is addressed.
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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-0001-2018 (July 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0001-2018 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.