FDA Recall Database: Class III Recall: PRIMIDONE by Lannett Company Inc.

Key facts

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Lannett Company Inc. and the affected product is described in FDA's record as: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.. FDA's stated reason for the recall is: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.. The recall is tracked under FDA recall number D-0533-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. -- and the recall number D-0533-2026. If it matches, stop using or distributing it and contact Lannett Company Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Lannett Company Inc.’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Lannett Company Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.) and recall number D-0533-2026, then follow Lannett Company Inc.'s recall instructions.

Has Lannett Company Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Lannett Company Inc., including 2 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0533-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions