FDA Issues Recall for Meclizine Hydrochloride Tablets

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 FDA has announced a voluntary recall of specific lots of Meclizine Hydrochloride Tablets due to failed specifications, affecting 697 cartons distributed nationwide.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 7, 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 recall was initiated because the tablets failed to meet specifications, as announced by the FDA.

Which Products Are Affected

The affected products are Meclizine Hydrochloride Tablets, USP 12.5 mg, specifically: (a) 50 Tablets [5 x 10] with NDC 60687-775-65, and (b) 12.5 mg Individual Dose with NDC 60687-775-11. A total of 697 cartons are involved, from lot number 1024852 with an expiration date of September 30, 2026. The recall affects products distributed nationwide in the United States.

What You Should Do

Consumers should stop using the affected tablets immediately and contact the recalling firm, Amerisource Health Services LLC, at their address: 2550 John Glenn Ave Ste A, Columbus, OH 43217-1188, for instructions on returns or refunds. The recall was initiated via letter.

Why This Matters

This recall involves a prescription drug that did not meet required standards, potentially posing risks to patient health, and underscores the need for adherence to quality controls in pharmaceuticals.

Source

FDA Recall Number: D-0418-2026. For more information, refer to the FDA's official resources.

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 FDA has announced a voluntary recall of specific lots of Meclizine Hydrochloride Tablets due to failed specifications, affecting 697 cartons distributed nationwide.
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.