Class I Recall for Zicam and Orajel Swab Products Due to Fungal Contamination

The US Food and Drug Administration (FDA) has issued a Class I recall affecting multiple swab-based over-the-counter drug products distributed by Church & Dwight Co., Inc., due to fungal contamination discovered in non-sterile products. The recall includes lots of Zicam Cold Remedy Medicated Nasal Swabs (3,374,918 cartons), Zicam Nasal AllClear (13 632 cartons), and Orajel Baby Cooling Swabs for Teething (695 880 cartons). The recall was initiated on June 6, 2025, and publicly announced via press release the same day, with FDA classification confirmed on July 3, 2025.

The recalling firm, Church & Dwight Inc., based in Princeton, New Jersey, initiated the recall voluntarily after identifying fungal contamination during quality testing. The FDA designated this as a Class I recall, its most serious classification, indicating that use of the affected products could lead to serious infections or life-threatening reactions, especially in vulnerable populations such as infants or immunocompromised individuals. The recall impacts products distributed nationwide across the United States.

The recalled products are intended for nasal symptom relief and teething discomfort: Zicam swabs deliver cold symptom support via intranasal application, while Orajel Baby swabs are used for soothing teething pain in infants. Due to the risk of fungal infection associated with non-sterile products applied to mucosal surfaces, pharmacists should immediately remove all affected swab lots from shelves, counsel patients on alternative symptom relief products, and report any adverse events.