One missing line about refrigeration — fifteen gallons, and the edge of Class II
A cold brew coffee concentrate from Fairhope Roasting Company was recalled because its label lacked a Keep Refrigerated statement although the product requires refrigeration. The quantity was fifteen gallons and the recall is terminated.
Recall overview (primary data)
- ClassificationClass II
- Product typeFood
- Recalling firmFairhope Roasting Company
- ReasonProduct requires refrigeration but the label is missing a "Keep Refrigerated" statement
- DistributionProduct distributed in AL for food service only
- Recall initiated2026-05-21
Key points
- The product is Fairhope Roasting Company Cold Brew Coffee Concentrate in one-gallon plastic jugs, UPC 852236006062.
- The reason for recall is that the product requires refrigeration but the label lacks a Keep Refrigerated statement.
- The quantity is fifteen gallons, distributed in Alabama for food service only.
- The recall began on 21 May 2026, was reported on 24 June, and its status is terminated.
- Among the 1,315 records without an article this site holds as of 2026-09-05, only 14 (1.1%) carry a terminated status.
1What was missing was one line
The series closes on the smallest record of the eight. Nothing is wrong with the product and nothing has got into it. What was missing was a line that belonged on the label: keep refrigerated.
2What a label carries
Whether a product is safe presumes that it is handled correctly. What tells anyone how to handle it is the label. Where the label is missing something, a sound product can still become unsafe from the handling side. This record shows that relationship in its plainest form.
3The smallest scale, and terminated
Fifteen gallons, and terminated. Of the 1,315 unpublished records only 14 (1.1%) have reached that status; most stay open in the published data. Where the reach is small and the recipients are known, a recall can actually be brought to a close.
4The eight records side by side
| What was wrong | What can be read as the ground for staying at Class II | The record |
|---|---|---|
| Scrap sensors were stolen and sold | The route does not change the class; infection and inaccuracy can be put right | Dexcom, May 2026 |
| The bottle held a different drug | The health consequences expected were assessed as reversible | Ajanta Pharma, May 2026 |
| An assay depressed the results beside it | The instrument's own quality control registers the fault | Siemens, July 2026 |
| A coil could not be detached mid-procedure | A route to completing the procedure by other means remains | Stryker, April 2026 |
| A shelf life had nothing behind it | Nothing has happened; correcting the labelled period suffices | TISSIUM, June 2026 |
| An emergency kit failed on gliding force | A twelve-month result; administration is impeded rather than prevented | Lupin, June 2026 |
| A pouch may release strips of plastic | Foreign matter, but serious consequences assessed as remote | CHEER PACK, July 2026 |
| A label lacked a refrigeration line | The product is sound; one line about handling is absent | Fairhope, May 2026 |
Set out together, the breadth Class II covers becomes visible. From stolen goods reaching pharmacies to a single missing line on a label, neither the cause nor the scale is alike. They share exactly one thing: an assessment that the health consequences reasonably expected are temporary or medically reversible, or that serious ones are remote.
That four in five records fall in this class says that a recall system runs on an estimate of what could happen rather than on harm that has.
Why it matters
Whether a product is safe presumes that it is handled correctly, and the label is what conveys how. Where the label is short a line, a sound product can become unsafe from the handling side. Class II, holding four in five of these records, stretches from stolen goods reaching pharmacies to a single omitted instruction, which is what a system running on estimates of what could happen, rather than on harm that has occurred, looks like.
FAQ
Why does a missing label statement warrant a recall?
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Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: H-0951-2026