Limited official informationFDA Drug Enforcement ReportsRecall date: May 27, 2026

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

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Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.	Lot#: 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.	44865 bottles	D-0533-2026

The agency's statement is shown without a site-authored severity score.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Agency classification: Class III

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

The linked agency record controls if any information differs.

Official scope

USA Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.