Vanilla Infused Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in…
Urban River Spirits recalled this product and the FDA reported the enforcement action on 14 August 2024 as Class III. The recall was initiated by the firm. Firm made non-alcoholic drink mixer in an unlicensed and uninspected facility. The product safety is concerned due to potential under-processing.
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
- Vanilla Infused Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
- Reason for recall
- Firm made non-alcoholic drink mixer in an unlicensed and uninspected facility. The product safety is concerned due to potential under-processing.
- Recalling firm
- Urban River Spirits
- Firm location
- Forest Grove, Oregon, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-1636-2024
- Quantity
- 3876 bottles total for all products
- Distribution
- Distributed in Arizona, Idaho, California, Colorado, Iowa, Florida, Oregon, Nevada, New Jersey, Texas, and Washington.
- Initiated
- 1 July 2024
- Reported by FDA
- 14 August 2024
- Terminated
- 13 August 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- None
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 is one of 24 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 24 separate recalls, which almost every published figure does, overstates it by a factor of 24. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 24 of them.
- The recall ran for 6 weeks, from 1 July 2024 to termination on 13 August 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 6 weeks after the firm began the recall.
- Recalls of a sauce, dip or condiment run a median of 6 months, so this one was shorter than usual for its category. 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
Process deviation
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation 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 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 114
- Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
- 21 CFR 117.150
- Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
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.
Other records from Urban River Spirits
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 23 other records name this firm.
All 24 records for Urban River Spirits
All 2024 recalls · All FDA food recall data
21 CFR 113 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.