Primidone Tablets USP Recall Issued by Lannett Company
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Lannett Company Inc. is recalling 44,865 bottles of Primidone Tablets USP, 250mg 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
Lannett Company Inc. initiated a voluntary recall of Primidone Tablets USP due to cross contamination with other products. The API was contaminated with trace amounts of Acemetacin API.
Which Products Are Affected
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. Affected lots include: 25283038A (Exp 1/31/2028); 25283564A, 25283565A (Exp 3/31/2028); 25285712A (Exp 08/31/2028); 25284105A (Exp 4/30/2028); 25284874A, 25284875A (Exp 08/31/2028). A total of 44,865 bottles are affected. Distribution was USA Nationwide.
What You Should Do
Consumers with questions should contact their healthcare provider or the recalling firm.
Why This Matters
This is an ongoing Class III recall affecting prescription medication distributed nationwide.
Source
FDA recall number D-0533-2026
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 (895 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.