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

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

**Manufacturer:** Lannett Company Inc.
**Date of action:** 20260527
**Canonical URL:** https://drugsmonitor.com/recall/868acb1f-799c-4bc2-a66b-69eb181dba8b
**Last updated:** 2026-06-11

## Summary

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. (Lannett Company Inc.) — Safety Label Change on 20260527.

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

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*