Primidone Tablets Recall Issued for Contamination
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (927 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to June 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.