Class II Recall Issued for Chlorpromazine Tablets Due to Nitrosamine Impurity

Glenmark Pharmaceuticals Inc., USA has initiated a voluntary Class II recall of its chlorproMAZINE Hydrochloride Tablets, USP 100 mg, due to current Good Manufacturing Practice (CGMP) deviations. The recall affects two specific lots—Lot# 17232222 and Lot# 17232237—with expiration dates of October 31, 2025. According to the FDA Enforcement Report, finished product testing revealed levels of a nitrosamine impurity, N-Nitroso-Desmethyl Chlorpromazine, that exceed the agency’s recommended limit. Nitrosamines are classified as probable human carcinogens, and their presence in pharmaceutical products remains a significant safety concern.

This recall, initiated on March 11, 2025, involves a total of 8160 bottles of 100 mg chlorpromazine tablets distributed across the US and Puerto Rico. Glenmark has notified its consignees via formal letter, and the recall remains ongoing as of the latest FDA classification date on April 2, 2025. While no press release has been issued at this time, the firm is actively managing the recall process in coordination with the FDA. The recall is considered Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health effects is remote.

Chlorpromazine is a prescription-only antipsychotic medication used primarily to treat psychotic disorders such as schizophrenia. It is also indicated for severe behavioral problems in children, nausea and vomiting, anxiety before surgery, and chronic hiccups. Pharmacists should immediately review inventory for the affected lots and follow the recall instructions issued by Glenmark to prevent further patient exposure to the impacted product.