Class II Recall for Multiple Strengths of Chlorpromazine Tablets Due to Contaminated Packaging Material

The US Food and Drug Administration (FDA) has issued a Class II recall affecting 4 strengths of Chlorpromazine Hydrochloride Tablets, USP—25 mg, 50 mg, 100 mg, and 200 mg—manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC, based in Bridgewater, New Jersey. The recall involves a total of 38 644 bottles, each containing 100 tablets, across multiple lots with expiration dates extending through June 30, 2027. The issue stems from the detection of a microorganism on a lot of auxiliary polyester coil used in product packaging. Importantly, no microbial contamination was found on the tablets themselves.

The recall was voluntarily initiated by Amneal Pharmaceuticals on August 18, 2025, and was officially classified as Class II by the FDA on September 4, 2025. A Class II recall indicates that exposure to the affected product may cause temporary or medically reversible health effects, with a low likelihood of serious consequences. While no contamination was found on the tablets, the potential for indirect microbial exposure through contact with the polyester coil warranted precautionary action. Amneal notified consignees via letter, and the products were distributed nationwide in the United States.

Chlorpromazine is a phenothiazine antipsychotic used to treat various psychiatric and medical conditions, including schizophrenia, bipolar disorder, severe behavioral problems in children, nausea, vomiting, and intractable hiccups. Given its wide therapeutic use and potential for long-term administration, ensuring product safety and packaging integrity is essential.