Real Alkalized Water, concentrate. 4 oz. glass bottle . Drinkrealwater.com
Real Water, Inc. recalled this product and the FDA reported the enforcement action on 28 April 2021 as Class I. The recall was initiated by the firm. FDA was notified of cases of acute liver failure after consumption of Real Water
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
- Real Alkalized Water, concentrate. 4 oz. glass bottle . Drinkrealwater.com
- Reason for recall
- FDA was notified of cases of acute liver failure after consumption of Real Water
- Recalling firm
- Real Water, Inc.
- Firm location
- Henderson, Nevada, United States
- Classification
- Class I
- Status
- Ongoing
- Recall number
- F-0482-2021
- Quantity
- unknown
- Distribution
- Nationwide. Distributors located in WA, CA, AZ, NM, NV, RI, CO, MN, MO, IL, TN, AL, MS, GA, NY
- Initiated
- 17 March 2021
- Reported by FDA
- 28 April 2021
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- All codes
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. 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 2 of them.
- This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
- The distribution pattern names 14 states, and the FDA published the enforcement report 6 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Named in the distribution pattern: California, Arizona, New Mexico, Nevada, Rhode Island, Colorado, Minnesota, Missouri, Illinois, Tennessee, Alabama, Mississippi, Georgia, New York. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Other records from Real Water, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2021-04-28 | Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. Drinkrealwater.com | Real Water, Inc. | FDA was notified of cases of acute liver failure after consumption of Real Water | Class I |
All 2021 recalls · All FDA food recall data
Behind every recall is a clause 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.