Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon…

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, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. 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-0481-2021

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

Real Water 16.9 oz., UPC (Case): 6-69149-10551-1, UPC (Single): 6-69149-10550-4 Real Water 1 Liter, UPC (Case): 6-69149-10553-5, UPC (Single): 6-69149-10552-8 Real Water 1.5 Ltr, UPC (Case): 6-69149-10555-9, UPC (Single): 6-69149-10554-2 Real Water 1 Gallon, UPC (Case): 6-69149-10561-0, UPC (Single): 6-69149-10560-3 ALL CODES of all products.

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. All 2 of them are listed on this page.
• 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.

Every product in this recall

The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

Other records from Real Water, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 2021 recalls · All FDA food recall data