Primidone Tablets Recall Issued by American Health Packaging
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Amerisource Health Services LLC is recalling Primidone Tablets, USP, 50 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, USP, 50 mg after the active pharmaceutical ingredient was found to be contaminated with trace amounts of Acemetacin API.
Which Products Are Affected
The recall covers Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11. Affected lots are Lot 1028739 (exp 12/31/2027) and Lot 1025622 (exp 06/30/2027). A total of 225,000 tablets are involved in the nationwide distribution.
What You Should Do
Consumers in possession of the affected product should consult their healthcare provider or pharmacist regarding next steps.
Why This Matters
This Class III recall addresses a low-risk contamination issue affecting a prescription anti-epileptic medication distributed across the United States.
Source
FDA recall D-0537-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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 (1,065 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.