FDA Issues Class II Recall for Millions of Eye Drop Bottles Over Sterility Risks

The FDA has announced a nationwide Class II recall of over 4.85 million packages of eye drops, initially issued by K.C. Pharmaceuticals, Inc. The recall, affecting products sold at major retailers, stems from a "lack of assurance of sterility," meaning the drops may contain harmful pathogens. A Class II risk level indicates potential for temporary or medically reversible adverse health consequences, prompting consumers to discontinue use immediately.