Class I Recall for OTC Laxative

Nearly 100,000 bottles of CVS Health Magnesium Citrate Saline Laxative are under a Class I recall because of microbial contamination. According to the July 13, 2022, US Food and Drug Administration (FDA) Enforcement Report, testing of the product identified the presence of Gluconacetobacter liquefaciens.

A Class I designation is the FDA’s most serious recall classification and warns that use of the affected product could cause serious adverse health consequences or death.

“Immunocompromised patients who consume this product may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences,” recalling firm Vi-Jon, LLC, stated in a June 22, 2022, company announcement. “To date, Vi-Jon, LLC has not received any complaints related to this recall.”

The recall affects CVS Health Magnesium Citrate Saline Laxative, oral solution, lemon flavor (UPC 0 50428 30594 2), 10 fl oz (296 mL), from lot 0556808 (Exp. 12/23). The product was distributed at CVS drug stores throughout the United States.

Vi-Jon voluntarily initiated the recall June 13, 2022. The FDA designated the recall Class I on July 5, 2022.

CVS Health Magnesium Citrate Saline Laxative is available over the counter for relief of occasional constipation.