U.S. painkillers and Indian eye drops recalled; Food and Drug Administration: None have been approved for import into the country

Painkillers in the United States have been recalled due to label discrepancies, and a manufacturing plant owned by Sun Pharmaceuticals in India has also been required to stop production of ophthalmic drugs and recall the products due to major deficiencies in pharmaceutical quality management. The Food and Drug Administration stated that after investigation, neither the above-mentioned drugs nor the manufacturing plants involved in the case had drug licenses or project input records approved by my country.

Jian Ren Jizheng and Liu Jiaping of the Drug Group of the Food and Drug Administration said that the U.S. Food and Drug Administration (FDA) issued recall information on October 14, 2026. Prodose Pharma's analgesic "ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg" was recalled due to inconsistent product labels. After checking my country's drug license database, this drug has not been approved domestically, and there is no relevant import record.

In response to foreign media reports that India's Sun Pharmaceutical Industries Ltd. has suspended the production of ophthalmic drugs and initiated recalls due to quality issues, Liu Jiaping pointed out that the manufacturer involved was the "Sun Pharma Laboratories Limited" manufacturing plant located in Assam, India.

The factory was jointly inspected by India's Central Drugs Standard Control Organization (CDSCO) and the local Drug Control Bureau. It was found that there were major systemic deficiencies in the pharmaceutical quality management system. The factory was required to completely stop the production of all ophthalmic products and initiate a preventive product recall.

Liu Jiaping said that the Assam manufacturing plant did not obtain a GMP approval letter issued by my country, nor did it have a drug license or project input record approved by my country.