Avantor Recalls Magnesium Sulfate Due to Impurity Failures
Avantor recalls 265 drums of Magnesium Sulfate 7-Hydrate for parenteral use due to failed impurity specifications. Check lot numbers 0000115590 and 0000117563.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Contact the company
What happened, in plain English
Avantor Performance Materials Inc is recalling Magnesium Sulfate 7-Hydrate intended for parenteral use because it failed to meet impurity specifications. The product was distributed in the US (including CA, IL, and NC) and Canada. No specific remedy or injury details are provided in the record. Read more at govinfonow.com/recall/43411-avantor-performance-materials-inc-recalls-magnesium-sulfate-7-hydrate-for.
Source Summary by GovInfoNow · govinfonow.com/recall/43411-avantor-performance-materials-inc-recalls-magnesium-sulfate-7-hydrate-for · Updated October 11, 2026 · FDA enforcement record: FDA #D-0563-2016
Cite this page
“Avantor Recalls Magnesium Sulfate Due to Impurity Failures.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43411-avantor-performance-materials-inc-recalls-magnesium-sulfate-7-hydrate-for. Based on FDA recall #D-0563-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0563-2016%22&limit=1).
Why it’s dangerous
The product failed impurity specifications, meaning it contained out-of-specification levels of impurities. For a drug intended for injection (parenteral use), such deviations can potentially compromise safety and efficacy, though the specific health consequences are not described in the record.
Who’s affected
Healthcare facilities or professionals who purchased this specific pharmaceutical-grade chemical for parenteral use between the manufacturing date and the expiry of May 10, 2017. The record does not specify which patients were at risk.
How to tell if you have this one
Look for Magnesium Sulfate 7-Hydrate labeled 'For Parenteral Use' from Avantor Performance Materials Inc. Check if the lot number is 0000115590 or 0000117563, both with an expiry date of 5/10/17. The product was sold in 100LB drums.
- Brand
Avantor Performance Materials- Category
Drug
What to do — step by step
Identify the Product
Verify if you have Magnesium Sulfate 7-Hydrate from Avantor Performance Materials Inc with lot numbers 0000115590 or 0000117563.
Contact the Manufacturer
Call Avantor Performance Materials Inc at 610-573-2600 for further instructions, as no specific remedy is listed in the recall record.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “Distributed in the US including: CA, IL & NC; Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, North Carolina.
Recall timeline
FDA terminated this recall 14 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.
Questions people ask
Where was this product sold?
It was distributed in the US, including California, Illinois, and North Carolina, as well as Canada.
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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-0563-2016 (October 30, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0563-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.