Reported May 27, 2026 · Ongoing

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

Lannett Company Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lannett Company Inc. · 1101 C Ave W · Seymour, IN · 47274-3342

Is this the product you have?

  • Primidone Tablets USP, 250mg, 100-count bottle, Rx only
  • Distributed byLannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01
Lot codes and dates
    • 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
Amount recalled
44865 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.