Antidepressant Recalled After Customer Report

Sun Pharmaceutical Industries Inc is recalling more than 10,000 bottles of bupropion hydrochloride extended-release tablets following a customer report of a dark, gritty substance in a bottle of medication. According to the May 18, 2022, US Food and Drug Administration (FDA) Enforcement Report, the grit “was determined to be activated carbon from the desiccant canister inside the bottle.”

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

• bupropion hydrochloride extended-release tablets, 150 mg, packaged in 60-count bottles (NDC 47335-737-86), from lots JKX5126A, JKX5127A, and JKX5128A (Exp. 10/22);
• bupropion hydrochloride extended-release tablets, 150 mg, packaged in 100-count bottles (NDC 47335-737-88), from lots JKX5126B and JKX5128B (Exp. 10/22);
• bupropion hydrochloride extended-release tablets, 150 mg, packaged in 500-count bottles (NDC 47335-737-13), from lots JKX5126C, JKX5127C, and JKX5128C (Exp. 10/22); and
• bupropion hydrochloride extended-release tablets, 200 mg, packaged in 60-count bottles (NDC 47335-738-86), from lot HAC2237A (Exp. 5/23).

Sun Pharmaceutical Industries voluntarily initiated the recall April 29, 2022. The FDA designated the recall Class III on May 10, 2022, suggesting use of the recalled product is not likely to cause harm.

Bupropion hydrochloride is a prescription antidepressant indicated for the treatment of major depressive disorder.