FDA Recall of Memantine Hydrochloride Extended-Release Capsules
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The Harvard Drug Group LLC is recalling specific lots of Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications, affecting products distributed nationwide in the United States.
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 "medium" 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
The Harvard Drug Group LLC is voluntarily recalling certain lots of Memantine Hydrochloride Extended-Release Capsules because they failed dissolution specifications, as classified by the FDA as a Class II recall.
Which Products Are Affected
The affected product is Memantine Hydrochloride Extended-Release Capsules, 7 mg, in 100-count packages (10 x 10 blister packs). The specific NDC is 0904-6734-61, with Lot # N02425 and expiration date of 05/31/2027. The distribution was US nationwide, and the quantity affected is not specified in the available data.
What You Should Do
Consumers who have the affected product should follow the initial firm notification, which was issued via letter, and contact The Harvard Drug Group LLC at their address: 7000 Cardinal Place, Dublin, OH 43017-1091, for information on returns or refunds. Do not use the product and consult a healthcare professional if you have concerns.
Why This Matters
This recall involves a prescription drug that failed quality specifications, potentially affecting its effectiveness and patient safety in the United States.
Source
Attribution: FDA Recall Number D-0485-2026. For more information, visit the FDA website or search for the recall using the event ID 98672.
Original source: FDA Official Notice ↗
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