Class III · Low risk
Primidone Tablets
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Is Primidone recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Primidone (6 total). Check the affected lots below.
Most common reason: Cross-contamination (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Primidone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Primidone recalls in 2026
6 initiated in 2026, 6 in total — newest first
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets USP
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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