Primidone Tablets Recalled Due to Cross Contamination

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for primidone tablets, USP, 50 mg. The affected batch has been identified as Lot AM251676 (expires November 2028), affecting 27 936 bottles, each containing 100 tablets.
• The recall was initiated by Amneal Pharmaceuticals due to cross contamination, a quality issue that is not likely to cause adverse health consequences.
• Primidone is used to treat epilepsy.

The FDA has issued a Class III recall for primidone tablets, USP, 50 mg, affecting 27 936 bottles, each containing 100 tablets. This medication is manufactured by Amneal Pharmaceuticals in India and is being recalled by the branch in Bridgewater, New Jersey. The recall was initiated on June 3, 2026, and received a Class III classification on June 10, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated due to a potential cross contamination with acemetacin. This deficiency affects Lot AM251676, which will expire in November 2028. Amneal Pharmaceuticals sent out a public notice via letter; no public press release has been issued for this recall.

Primidone is a prescription medication used to treat epilepsy by controlling and reducing seizures. Pharmacists should identify and quarantine Lot AM251676, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 17, 2026. Accessed June 17, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220942