Avantor Potassium Phosphate Recall: High Iron Content Risk
Avantor recalls potassium phosphate products with high iron content that may fail stability tests. Check product numbers and batch dates for affected items.
Lower-risk recall
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
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What happened, in plain English
Avantor is recalling potassium phosphate products that contain excessive iron, which could lead to instability in pharmaceutical formulations. This affects specific packaging sizes and batch numbers. Read more at govinfonow.com/recall/37775-avantor-potassium-phosphate-recall-high-iron-content-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37775-avantor-potassium-phosphate-recall-high-iron-content-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0575-2020
Cite this page
“Avantor Potassium Phosphate Recall: High Iron Content Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37775-avantor-potassium-phosphate-recall-high-iron-content-risk. Based on FDA recall #D-0575-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0575-2020%22&limit=1).
Why it’s dangerous
The product contains iron levels above specified limits, which could cause instability in pharmaceutical formulations. This may lead to product failure during manufacturing or storage.
Who’s affected
Pharmaceutical manufacturers using these potassium phosphate products may be affected. Those handling high-iron content products in bulk pharmaceutical manufacturing are most at risk.
How to tell if you have this one
Check for product numbers 3248-01, 3248-05, 3248-07, 3248-X2, 3248-X3, or 7390-19. Look for batch numbers listed in the description, such as 0000226380 or 0000224662.
- Brand
Avantor- Category
Drug
What to do — step by step
Check Product Numbers
Identify affected products by checking the product numbers listed in the recall notice.
Verify Batch Numbers
Confirm the batch numbers match those listed in the recall (e.g., 0000226380, 0000224662).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide in the USA, Canada, India, and Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What batch numbers are included in this recall?
Batch numbers include 0000226380, 0000224662, 0000224663, 0000227641, and others as listed in the recall notice.
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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-0575-2020 (October 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0575-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.