June 1, 2026: Up to 18 years for counterfeit pill conspirators in Massachusetts 

The FDA warned an over-the-counter drug (OTC) manufacturer in Japan, in part, for failures in the design of its aseptic filling line. The FDA noted that since 2022, at least six media fill failures have been reported and “significant microbiological and foreign particulate contamination has been found in this line.” The FDA also said the firm did not have adequate stability testing to prove that products remained acceptable throughout their shelf life, and did not adequately conduct required microbial testing.  

An Illinois-based manufacturer of OTC drug products, including children's toothpaste, was warned for failing to ensure components in their drugs were acceptable for use, noting a lack of chemical purity, microbial quality, and high-risk components testing. The agency also noted inadequate stability testing and uncontrolled data systems. 

An Indian active ingredient manufacturer was warned for significant facility disrepair, including rust-like residue on product-contact surfaces, wet paint while drug production was ongoing, and dripping overhead water from condensation that led to standing water around manufacturing areas. 

Finally, the FDA also warned two companies, including one in Canada, for marketing nasal sprays used to treat headaches, unapproved new drugs. One spray is marketed as cayenne pepper headache spray, which is not permitted as an active ingredient.