FDA Recall of Memantine Hydrochloride Extended-Release Capsules

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.