FDA Announces Recall of American Health Packaging Carbamazepine Tablets Over Dissolution Failure

American Health Packaging has voluntarily initiated a Class II recall of carbamazepine extended-release tablets, USP 400 mg, due to failed dissolution specifications that could affect the drug’s therapeutic effectiveness. The recalled product was distributed in 30-tablet cartons (3x10 unit dose cards) under NDC 60687-594-21 and individual dose NDC 60687-594-11. The affected lot number is 1024078, with an expiration date of August 31, 2026. Manufactured for American Health Packaging in Columbus, Ohio, the recall impacts 360 cartons distributed nationwide in the United States.

The US Food and Drug Administration (FDA) classified the recall as Class II on September 29, 2025, following the firm’s voluntary recall initiation on September 15, 2025. According to the FDA Enforcement Report, the product failed dissolution testing, indicating that some tablets may not properly release the active ingredient over time. This could result in suboptimal drug absorption and reduced efficacy, potentially leading to inadequate seizure control or therapeutic failure. American Health Packaging notified affected consignees by letter, and the recall remains ongoing. No public press release has been issued.

Carbamazepine Extended-Release Tablets are indicated for the treatment of epilepsy, specifically for the management of partial seizures and generalized tonic-clonic seizures. The medication is also prescribed for trigeminal neuralgia to reduce nerve pain. Pharmacists should review their inventory for the affected lot, counsel patients accordingly, and ensure continuity of therapy with unaffected product to prevent disruption in seizure management.

Reference

FDA. Enforcement Report. October 8, 2025. Accessed October 8, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=215926