FDA WARNING_LETTER - New Life Pharma Limited Liability Company - February 13, 2026

New Life Pharma LLC received an FDA Warning Letter on April 14, 2026, following an inspection from February 3 to February 13, 2026, at its Northvale, New Jersey facility. The FDA identified severe violations of the Federal Food, Drug, and Cosmetic (FD&C) Act, primarily involving the distribution of unapproved and misbranded drug products. Specifically, the company marketed injectable Semaglutide and Tirzepatide vials without approved applications and failed to accurately register its facility or list its products with the agency.

The inspection also revealed critical failures in Current Good Manufacturing Practice (CGMP). The firm lacked procedures to prevent microbiological contamination, failed to validate sterilization processes, and did not maintain appropriate cleanroom standards for sterile drugs. Additionally, the quality control unit failed to test components for identity and purity. Notably, the firm obstructed the inspection by denying investigators access to certain manufacturing areas, leading the FDA to deem the products adulterated.

While New Life Pharma initiated a voluntary recall in February 2026 and paused operations, the FDA remains concerned about the facility"s ability to produce safe, sterile products. The agency has directed the company to provide a written response within 15 working days detailing its corrective actions and strongly recommends that drug manufacturing at this facility not resume. Failure to address these concerns may lead to further legal action, such as product seizures or injunctions.