Primidone Tablets Recall Issued for Contamination

Source: FDA · United States

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Amerisource Health Services LLC is recalling Primidone Tablets, USP, 250 mg due to cross-contamination with trace amounts of Acemetacin API.

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

This notice was issued by FDA on June 10, 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.

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

Amerisource Health Services LLC initiated a voluntary recall of Primidone Tablets after the active pharmaceutical ingredient was found to be contaminated with trace amounts of Acemetacin API.

Which Products Are Affected

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11. Lot#: 1027583, Exp 09/30/2027. A total of 63,500 tablets are affected. The recall is nationwide in the United States.

What You Should Do

Consumers should contact their physician or healthcare provider if they have questions about the affected product. The recall is ongoing.

Why This Matters

This Class III recall involves a prescription anti-epileptic drug distributed across the United States.

Source

FDA recall number D-0536-2026, report date 20260527.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Amerisource Health Services LLC is recalling Primidone Tablets, USP, 250 mg due to cross-contamination with trace amounts of Acemetacin API.
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 "low" severity. No immediate action required, but stay aware.
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.