Class IITerminated · reported 2022-06-29

Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural…

Abbott Laboratories recalled this product and the FDA reported the enforcement action on 29 June 2022 as Class II. The recall was initiated by the firm. These products are being recalled due to the potential of leakage from the 1L container.

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
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
Reason for recall
These products are being recalled due to the potential of leakage from the 1L container.
Recalling firm
Abbott Laboratories
Firm location
Columbus, Ohio, United States
Classification
Class II
Status
Terminated
Recall number
F-1344-2022
Quantity
121,918 (2-count cases)
Distribution
AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MI, MO, MS, NC, NH, NY, OH, OR, PA, TN, TX, UT, VA and WI
Initiated
3 June 2022
Reported by FDA
29 June 2022
Terminated
14 April 2023
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
30289SG00, 30290SG00, 30291SG00, 30292SG00, 30293SG00, 30294SG00, 35409SG00, 35410SG00, 35411SG00, 35412SG00, 36435SG00, 36434SG00, 36433SG00, 36432SG00, 37444SG00, 37443SG00, 37442SG00, 37441SG00, 37440SG00, and 41129D500.

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 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.
  • The recall ran for 10 months, from 3 June 2022 to termination on 14 April 2023. 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 distribution pattern names 28 states, and the FDA published the enforcement report 4 weeks after the firm began the recall.
  • Recalls of fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.

Named in the distribution pattern: Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Filed under fresh produce and beverages and juice. A product can sit in more than one.

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.

The other 1 records of FDA event 90379
ReportedProductFirmReasonClass
2022-06-29Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USAAbbott LaboratoriesThese products are being recalled due to the potential of leakage from the 1L container.Class II

Other fresh produce recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

ReportedProductFirmReasonClass
2026-09-02Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.Dreyer's Grand Ice Cream Inc.Foreign object: products may contain glass piecesClass II
2026-09-02Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.CUISINE, KETTLEProduct had a presumptive positive test result for Listeria monocytogenesClass II
2026-09-02Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Peppers, Garlic, Onions, Water, Distilled 5% White Vinegar, Spices***Manufactured and Packed By Africando Foods, LLC 1121S Gilbert Ct. Iowa City, IA 52240***"Africando Foods LLCLabeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient listUnclassified
2026-09-02Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.Dreyer's Grand Ice Cream Inc.Foreign object: products may contain glass piecesClass II
2026-09-02Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041548816678, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.Dreyer's Grand Ice Cream Inc.Foreign object: products may contain glass piecesClass II
2026-08-26Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I
2026-08-26Organic Whole Mixed Berries, Net Wt. 10 oz (284 g) plastic bags, packed in 8 bags per case of 10 oz each. Keep Frozen. UPC 41415-06753Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I
2026-08-26Organic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep Frozen UPC 41415-06453Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I

Other records from Abbott Laboratories

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 60 other records name this firm.

ReportedProductFirmReasonClass
2023-11-15Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.Abbott LaboratoriesMarketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additiveClass II
2023-04-19Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard cartonAbbott LaboratoriesPotential of foreign material (hard plastic) within productClass II
2022-11-23Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kitAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count cartonAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count cartonAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II

All 61 records for Abbott Laboratories

All 2022 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 access

Recall 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.