Primidone Tablets Recall Due to Cross Contamination

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.

Golden State Medical Supply Inc. is recalling 8,526 bottles of 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

Golden State Medical Supply Inc. 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 due to cross contamination with other products.

Which Products Are Affected

The recall covers Primidone Tablets, USP, 50 mg, 50-count bottles (NDC 51407-637-05), RX only, manufactured by Lannett Company, Inc. and marketed by GSMS, Incorporated. Affected lots include GS066750, GS067084, GS067710, GS067873 (Exp 3/31/2028) and GS068339, GS068897 (Exp 8/31/2028). A total of 8,526 bottles were distributed nationwide in the United States.

What You Should Do

Consumers should contact their physician or pharmacist regarding use of the affected product. For questions about the recall, contact Golden State Medical Supply Inc. at their Camarillo, CA facility.

Why This Matters

This Class III recall addresses a product quality issue involving trace cross contamination in a prescription anti-epileptic medication distributed across the United States.

Source

FDA recall D-0534-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Golden State Medical Supply Inc. is recalling 8,526 bottles of Primidone Tablets, USP, 50 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.