Little Remedies¿ Honey Cough 4 FL OZ (118 mL)
Prestige Brands Holdings recalled this product and the FDA reported the enforcement action on 23 July 2025 as Class II. The recall was initiated by the firm. contaminated with Bacillus cereus and may be spoiled
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Little Remedies¿ Honey Cough 4 FL OZ (118 mL)
- Reason for recall
- contaminated with Bacillus cereus and may be spoiled
- Recalling firm
- Prestige Brands Holdings
- Firm location
- Tarrytown, New York, United States
- Classification
- Class II
- Status
- Ongoing
- Recall number
- H-0260-2025
- Quantity
- 10,223 cases (245,352 units)
- Distribution
- Nationwide
- Initiated
- 18 June 2025
- Reported by FDA
- 23 July 2025
- Firm notified by
- Press Release
- Product codes
- 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
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
- The FDA published the enforcement report 5 weeks after the firm began the recall.
- Sauces and dips sit at the intersection of the acidified foods rule and the allergen rule: an equilibrium pH above 4.6 turns a shelf-stable product into a botulism risk, and the ingredient list is long enough that an allergen is easy to lose.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
Filed under sauces, dips and condiments. A product can sit in more than one.
Other sauces, dips and condiments recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2025 recalls · All FDA food recall data
21 CFR 117.93 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.