A 245,000-Bottle Cough Medicine Recall Now Comes with More Details

In June, the U.S. Food and Drug Administration (FDA) announced the recall of five lots of Little Remedies Honey Cough Syrup due to the potential for foodborne illness. Now, there are updates on the scale of the issue and more insight into the danger.

The FDA has shared new details about the over-the-counter cough medicine recall, reporting that 10,223 cases were affected—for a total of 245,352 bottles, according to the notice. Originally, the report only indicated that five lots were involved in the recall.

While the original FDA alert stated the recall was due to the “presence of Bacillus cereus and loss of shelf-stability,” the agency now lists the reason as “contaminated with Bacillus cereus and may be spoiled.” Bacillus cereus (B. cereus) is a microscopic spore-forming bacteria that can cause food poisoning, explains the Cleveland Clinic.

The Little Remedies Honey Cough Drop label lists ingredients as honey, purified water, and ε-Polylysine, which they call a “natural preservative.” The National Institutes of Health speaks to the “antimicrobial mechanism” of this amino acid that occurs from fermentation. It’s been used as a preservative in the United States since the 1980s, but it’s under the FDA’s category of substances that are “Generally Recognized as Safe” (GRAS). This designation can indicate that some question remains about its safety.

As a reminder, the recalled bottles were distributed throughout the country from December 14, 2022, to June 4, 2025, and were sold both in-store and online. Further details about the recall are as follows:

• Little Remedies Honey Cough 4 FL OZ (118 mL)
• UPC: 7-56184-10737-9
  • Lot: 0039, Expiration: 11/2025
  • Lot: 0545, Expiration: 01/2026
  • Lot: 0640, Expiration: 02/2026
  • Lot: 0450, Expiration: 05/2026
  • Lot: 1198, Expiration: 12/2026
• Company name: Medtech Products Inc.
• Recalling firm: Prestige Brands Holdings in Tarrytown, New York

The FDA has deemed the recall as a Class II risk, suggesting that use of the cough medicine could “cause temporary or medically reversible adverse health consequences.”

In a press release shared in June, the company behind Little Remedies, Medtech Products Inc., advised consumers to stop using the product and to “contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this Product.”

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