Anticonvulsant Recalled

Sun Pharmaceutical Industries Inc is recalling 3 lots of oxcarbazepine tablets. The recall announcement, included in the December 28, 2022, US Food and Drug Administration (FDA) Enforcement Report, cited the presence of a foreign substance as the reason for the recall but provided no further detail.

The recall affects the following products, which were manufactured by Sun Pharmaceutical Industries Limited, Gujarat, India, and distributed throughout the United States by Sun Pharmaceutical Industries Inc, Cranbury, New Jersey:

• 600-mg oxcarbazepine tablets, 100-count bottles (NDC 62756-185-88), from lot HAC1474A (Exp. 3/23);
• 600-mg oxcarbazepine tablets, 500-count bottles (NDC 62756-185-13), from lot HAC1503A (Exp. 3/23); and
• 600-mg oxcarbazepine tablets, 1000-count bottles (NDC 62756-185-18), from lot HAC1474B (Exp. 3/23).

Sun Pharmaceutical Industries voluntarily initiated the recall December 1, 2022. On December 19, 2022, the FDA designated the recall Class II, signaling use of the drug could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Oxcarbazepine is a prescription anticonvulsant used to treat partial-onset seizures.