Food recall: Little Remedies Honey Cough 4 FL OZ (118 mL)
Class II FDA enforcement event 97088. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
contaminated with Bacillus cereus and may be spoiled
Class II, in the words of FDA
a situation in which 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
Prestige Brands Holdings started this food recall on 18 Jun 2025. The firm address in the FDA record is in Tarrytown, NY. FDA put the recall in Class II. FDA event 97088 has 1 product record. The first FDA enforcement report date is 23 Jul 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Prestige Brands Holdings, Tarrytown, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| H-0260-2025 | Little Remedies Honey Cough 4 FL OZ (118 mL) | 10,223 cases (245,352 units) | Class II | Ongoing | 23 Jul 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2025
- 569
- Share of these events in Class II
- 54%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2026 | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarr | Drug | Class II | 1 |
| 25 Apr 2014 | PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 m | Drug | Class III | 2 |
Official channels
- FDA enforcement report H-0260-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 97088. https://recallregister.com/fda/ii/97088/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 97088?
- The FDA record gives this quantity:
10,223 cases (245,352 units)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2025 have the same class?
- 54% of the 569 food events that started in 2025 are in Class II.