Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performanc
Summary
The FDA issued a Class III for Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceuti by Avantor Performance Materials LLC. Reason: Subpotent drug.
Details
Source
Drug Recall
External ID
D-0488-2026
Action Date
2026-04-22
Status
Ongoing
Category
drug
Product Description
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Lot/Code Info: Lot 23G3161005, Exp 9/21/2027
Quantity Affected: 36 bottles
Reason for Recall
Subpotent drug
Distribution
Nationwide in the USA, Belgium and France
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-31
Company
Paris, KY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 94 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avantor Performance Materials LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Avantor Performance Materials LLC have FDA actions?
This is the only FDA action we have on record for Avantor Performance Materials LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0488-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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