Recall of Magnesium Chloride by Avantor Performance Materials LLC
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Avantor Performance Materials LLC is voluntarily recalling 36 bottles of Magnesium Chloride, 6-Hydrate due to subpotency, affecting lot 23G3161005 distributed nationwide in the USA and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Avantor Performance Materials LLC is recalling certain lots of Magnesium Chloride, 6-Hydrate because it is subpotent, meaning the drug may not meet the required potency standards. This is a voluntary, firm-initiated recall classified as Class III by the FDA.
Which Products Are Affected
The affected product is Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, a bulk active pharmaceutical ingredient (API) with NDC 10106-2448-1. The recall involves 36 bottles from lot 23G3161005, with an expiration date of 9/21/2027. Distribution occurred nationwide in the USA, as well as in Belgium and France.
What You Should Do
Consumers should follow the initial firm notification, which is a letter from Avantor Performance Materials LLC. Contact the firm at their address: 7001 Martin Luther King Jr Blvd, Paris, KY 40361-2147, for information on returns or refunds.
Why This Matters
This recall highlights potential quality issues in pharmaceutical ingredients, which could affect drug efficacy, though the Class III classification indicates a low risk of adverse health consequences. It underscores the importance of monitoring drug potency in the supply chain.
Source
The recall information is from the FDA, recall number D-0488-2026. For more details, visit the FDA website at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts and search for recall number D-0488-2026.
Original source: FDA Official Notice ↗
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