RecallHawk
Class II Recall

Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case

Abbott Laboratories

Summary

The FDA issued a Class II for Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 cou by Abbott Laboratories. Reason: Compromised seal integrity which could lead to spoilage.

Details

Source

Food Recall

External ID

F-0155-2023

Action Date

2022-11-23

Status

Terminated

Category

food

Product Description

Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case

Lot/Code Info: Batch No. 34589N200 Case No. 34589N200 Product No. 5989213 Best By 04/01/23

Quantity Affected: 14,588,544 bottles TOTAL

Reason for Recall

Compromised seal integrity which could lead to spoilage

Distribution

Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming Foreign: Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia

Type: Voluntary: Firm initiated

Recall Initiated: 2022-10-13

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 32 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Abbott Laboratories have FDA actions?

Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0155-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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