# 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/78af3e5b-b1fc-4e7e-838c-9e48f538f80a
**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.

---

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