Sparta, New Jersey, August 25, 2025
The U.S. Food & Drug Administration (FDA) recently posted information about the voluntary recall of an over-the-counter (OTC) cough syrup by its manufacturer. A total of five lots of the cough syrup for children and adults are part of the recall due to concerns over Bacillus cereus contamination and loss of shelf-stability.
According to the recall notice:
Bacillus cereus (B. cereus) can cause two types of food-borne illnesses. One type is characterized by nausea, vomiting, and stomach cramps that can start 1 to 6 hours after eating or drinking contaminated food. The second type can cause stomach cramps and diarrhea that can start 8 to 16 hours after eating or drinking contaminated food. Diarrhea may be a small volume or profuse and watery. Although healthy individuals may suffer only short-term illness, exposure to high levels of foodborne B. cereus can cause death.
The manufacturer reports that the affected lots were distributed nationwide through retailers and online from 12/14/2022 through 06/04/2025. Consumers that have the recalled product are advised to stop using it immediately.
Dedicated to preventing contaminated OTC medicines, supplements, pharmaceuticals, personal care products, and other consumer goods from reaching the public, and the high costs associated with these types of recalls, are the dedicated scientists at MPL Laboratories. Their product testing facility is FDA registered and DEA licensed and provides cGMP and ISO 17025 compliant sterility and microbiology testing. MPL’s services and expertise can be essential for assessing raw ingredients, production processes and surfaces, and final products. These resources are available to manufacturers, importers, distributors, retailers, regulatory agencies, healthcare providers, and the public.
To learn more about product testing services offered by MPL Laboratories, please visit www.MPLLaboratories.com, call (800) 548-1874, or email info@MPLLaboratories.com.
About MPL Laboratories
MPL Laboratories (formerly Marypaul Laboratories) was founded in 1985 as a full service microbiology laboratory. It is ISO/IEC 17025 accredited by PJLA, FDA, and DEA registered. MPL’s staff includes a Ph.D. Diplomat of the American Board of Toxicology, M.S. and B.S. degreed microbiologists, along with other dedicated scientific personnel. The microbiology testing laboratory serves the pharmaceutical, cosmetic, and personal care product industries. MPL strives to provide its clients with reliable, defensible test data delivered in a timely manner. The laboratory is part of the EMSL Analytical network of laboratories across the United States and Canada.
