FDA Class III Recall: Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk… by Avantor Performance Materials LLC

Key facts

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number D-0488-2026. If it matches, stop using or distributing it and contact Avantor Performance Materials LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Avantor Performance Materials LLC and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: Subpotent drug. The recall is tracked under FDA recall number D-0488-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Avantor Performance Materials LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Avantor Performance Materials LLC: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Avantor Performance Materials LLC had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Avantor Performance Materials LLC so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number D-0488-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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