FDA Issues Risk Warning for Nationwide Cough Syrup Recall

Newsweek

3 days ago

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A recall of cough syrup due to potential bacterial contamination has been issued the second-highest risk warning by the U.S. Food and Drug Administration (FDA).
Prestige Consumer Healthcare Inc., based in New York, issued a voluntary recall for more than 10,000 cases of its honey cough syrup on June 17 because they may have been spoiled by the bacterium Bacillus cereus.
The FDA subsequently issued a Class II risk warning for the recall on July 11.
Newsweek contacted Prestige Consumer Healthcare Inc. for comment by email outside of regular working hours.
Prestige Consumer Healthcare Inc. issued a voluntary recall for more than 10,000 cases of its honey cough syrup on June 17, 2025.
Prestige Consumer Healthcare Inc. issued a voluntary recall for more than 10,000 cases of its honey cough syrup on June 17, 2025.
Heiko Wolfraum/picture-alliance/dpa/AP Images
Why It Matters
A Class II risk classification refers to a situation in which the "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the FDA.
The FDA warned in its recall notice that Bacillus cereus may lead to two forms of food-borne illnesses. The first can cause symptoms including nausea, vomiting and stomach cramps that typically develop between one and six hours after consuming contaminated food.
The second form of illness often causes stomach cramps and diarrhea that start between eight and 16 hours after consuming the contaminated product.
The FDA added: "Although healthy individuals may suffer only short-term illness, exposure to high levels of foodborne B. cereus can cause death."
What To Know
The product affected by the recall is Little Remedies Honey Cough Syrup - UPC code: 7-56184-10737-9 - Lot codes: 0039 / 0545 / 0640 / 0450 / 1198 - expiry dates: 11/2025 / 01/2026 / 02/2026 / 05/2026 / 12/2026.
A total of 245,352 units are impacted by the recall, and they were distributed nationwide to retailers and online from 12/14/2022 to 06/04/2025.
The recall does not include other Little Remedies products, the agency said.
As of June 18, no illnesses had been reported in connection to the consumption of the affected product.
What People Are Saying
The FDA, in a report: "Bacillus cereus is an aerobic spore-forming bacterium that is commonly found in soil, on vegetables, and in many raw and processed foods. B. cereus food poisoning may occur when foods are prepared and held without adequate refrigeration for several hours before serving, with B. cereus reaching >106 cells/g. Foods incriminated in past outbreaks include cooked meat and vegetables, boiled or fried rice, vanilla sauce, custards, soups, and raw vegetable sprouts."
The FDA, in its alert: "Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax."
What Happens Next
The recall is listed as ongoing, according to the FDA.
Consumers who are in possession of the recalled cough syrup should stop using it immediately and contact their health care provider if they experience any symptoms related to the use of it, the FDA said.
The company will offer refunds to consumers who bought the product from the recalled lots.