The U.S. Food and Drug Administration announces a nationwide voluntary cough drops recall involving several over-the-counter cough drops and throat lozenges after manufacturing inspections raised product quality concerns that could cause temporary health effects.
FDA Issues Recall After Inspection Raises Manufacturing Concerns
The U.S. Food and Drug Administration says multiple cough drops and throat lozenges sold across the United States are being voluntarily recalled following findings from a manufacturing facility inspection.
The cough drops recall was initiated by Xiamen Kang Zhongyuan Biotechnology, based in Xiamen, China, after FDA inspectors noted concerns during an Aug. 15, 2025, inspection that could affect product quality.
The agency classifies the action as a Class II recall, meaning exposure to the products may cause temporary or medically reversible adverse health consequences, but serious health risks are unlikely.
“The recall is being conducted out of an abundance of caution,” the FDA says in its public notice. Officials add that the inspection observations prompted further review of manufacturing practices.
The FDA does not disclose specific contamination or defect details but says the issues may impact product safety and effectiveness.
Multiple Retail Brands And Products Affected Nationwide
The cough drops recall affects several widely distributed store brands and private-label products sold nationwide through retail stores, online platforms, and military exchanges.
Affected products include Exchange Select honey lemon and menthol cough drops manufactured for military exchange stores, Caring Mill cherry cough drops distributed by FSA Store Inc., and Discount Drug Mart Food Market honey lemon cough drops.
Also included are MGC Health sugar-free honey lemon cough drops in multiple package sizes and several QC Quality Choice products distributed by CDMA Inc.
QC Quality Choice items subject to the cough drops recall include black cherry, honey lemon, menthol, vanilla honey, and creamy strawberry throat soothing drops, offered in both sugar-free and regular varieties.
The FDA advises consumers to check packaging labels carefully and avoid using products listed in the recall announcement.
FDA Urges Consumers To Stop Use And Monitor Symptoms
Health officials say consumers who have purchased the recalled cough drops or lozenges should stop using them immediately and dispose of the products or return them to the place of purchase.
According to the FDA, Class II recalls typically involve products that may cause short-term or reversible medical issues. No widespread serious injuries linked to the products are reported at this time.
Medical experts say consumers should seek medical advice if they experience unusual symptoms after using the products.
“While the risk level is considered moderate, recalls help prevent potential harm before problems escalate,” says a statement from FDA safety officials.
The agency continues to monitor the situation and may provide additional updates as investigations into manufacturing conditions proceed.
Consumers can access full details of the cough drops recall, including lot numbers and distribution information, through the FDA’s official recall database.
Key Takeaways
- The U.S. FDA announced a nationwide voluntary recall of several over-the-counter cough drops and throat lozenges.
- The cough drops recall follows manufacturing quality concerns found during an Aug. 15, 2025, facility inspection in China.
- The action is classified as a Class II recall, meaning products may cause temporary or reversible health effects.
- Multiple brands, including Exchange Select, Caring Mill, MGC Health, and QC Quality Choice, are affected.
- Consumers are advised to stop using recalled products immediately and return or safely dispose of them.
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