RecallHawk
Class II Recall

Vicks Children's Botanicals Liquid Daytime/Nighttime Combo Pack 4oz plastic bottles

The Procter & Gamble Company

Summary

The FDA issued a Class II for Vicks Children's Botanicals Liquid Daytime/Nighttime Combo Pack 4oz plastic bot by The Procter & Gamble Company. Reason: Acidified/Low Acid dietary supplement with no approved process..

Details

Source

Food Recall

External ID

F-1533-2022

Action Date

2022-08-10

Status

Terminated

Category

food

Product Description

Vicks Children's Botanicals Liquid Daytime/Nighttime Combo Pack 4oz plastic bottles

Lot/Code Info: Batch Numbers: 0240C60405, 0314C60402, 11664334R1, 11664334R2, 11664334R3, 11664334R4, 11664334R5, 11664334E1, 12164334E1, 12164334E2, 12164334Y1, 12164334Y2, 12164334Y3, 12164334Y4, 12164334Y5, 12164334Y6, 12184334E1, 12184334E2, 12184334E3, 12184334E4, 12184334Y1, 12184334Y2, 12184334Y3, 12184334Y4, 12374334D1, 12374334D2, 12374334E0, 12374334E1, 12374334E2, 12374334E3, 12374334E4, 12374334E5, 12374334E6, 12374334E7, 12374334E8, 12374334E9, 12374334EA, 12374334Y1, 12374334Y2, 13214334D1, 13214334D2, 13214334J1, 13214334K0, 13214334K1, 13214334K2, 13214334K3, 13214334K4, 13214334K5, 13214334K6, 13214334K7, 13214334K8, 13214334K9, 13214334P1, 13214334P2, 13624334S1, 20124334E1, 20124334E2, 20124334E3, 20124334K1, 20124334K2, 20124334K3, 20124334K4, 20384334E1, 20384334E2, 20384334E3 Lot Numbers: 0240C60405, 0314C60402, 11664334R1, 11664334R2, 11664334R3, 11664334R4, 11664334R5, 11664334E1, 12164334E1, 12164334E2, 12164334Y1, 12164334Y2, 12164334Y3, 12164334Y4, 12164334Y5, 12164334Y6, 12184334E1, 12184334E2, 12184334E3, 12184334E4, 12184334Y1, 12184334Y2, 12184334Y3, 12184334Y4, 12374334D1, 12374334D2, 12374334E0, 12374334E1, 12374334E2, 12374334E3, 12374334E4, 12374334E5, 12374334E6, 12374334E7, 12374334E8, 12374334E9, 12374334EA, 12374334Y1, 12374334Y2, 13214334D1, 13214334D2, 13214334J1, 13214334K0, 13214334K1, 13214334K2, 13214334K3, 13214334K4, 13214334K5, 13214334K6, 13214334K7, 13214334K8, 13214334K9, 13214334P1, 13214334P2, 13624334S1, 20124334E1, 20124334E2, 20124334E3, 20124334K1, 20124334K2, 20124334K3, 20124334K4, 20384334E1, 20384334E2, 20384334E3 Product Number: 80338569, 80365757 Item UPC: 323900041073 Case UPC: 10323900041070 Expiration Dates: 0240C60405 07/31/2022, 0314C60402 10/31/2022, 11664334R2 - 05/31/2023, 11664334R3 - 05/31/2023, 11664334R4 - 05/31/2023, 11664334R5 - 05/31/2023, 11664334E1 - 05/31/2023, 12164334E1 07/31/2023, 12164334E2 - 07/31/2023, 12164334Y1 - 07/31/2023, 12164334Y2 - 07/31/2023, 12164334Y3 - 07/31/2023, 12164334Y4 - 07/31/2023, 12164334Y5 - 07/31/2023, 12164334Y6 - 07/31/2023, 12184334E1 - 07/31/2023, 12184334E2 - 07/31/2023, 12184334E3 - 07/31/2023, 12184334E4 - 07/31/2023, 12184334Y1 - 07/31/2023, 12184334Y2 - 07/31/2023, 12184334Y3 - 07/31/2023, 12184334Y4 - 07/31/2023, 12374334D1 - 07/31/2023, 12374334D2 - 07/31/2023, 12374334E0 - 07/31/2023, 12374334E1 - 07/31/2023, 12374334E2 - 07/31/2023, 12374334E3 - 07/31/2023, 12374334E4 - 07/31/2023, 12374334E5 - 07/31/2023, 12374334E6 - 07/31/2023, 12374334E7 - 07/31/2023, 12374334E8 - 07/31/2023, 12374334E9 - 07/31/2023, 12374334EA - 07/31/2023, 12374334Y1 - 07/31/2023, 12374334Y2 - 07/31/2023, 13214334D1 10/31/2023, 13214334D2 - 10/31/2023, 13214334J1 - 10/31/2023, 13214334K0 - 10/31/2023, 13214334K1 - 10/31/2023, 13214334K2 - 10/31/2023, 13214334K3 - 10/31/2023, 13214334K4 - 10/31/2023, 13214334K5 - 10/31/2023, 13214334K6 - 10/31/2023, 13214334K7 - 10/31/2023, 13214334K8 - 10/31/2023, 13214334K9 - 10/31/2023, 13214334P1 - 10/31/2023, 13214334P2 - 10/31/2023, 13624334S1 10/31/2023, 20124334E1 12/31/2023, 20124334E2 - 12/31/2023, 20124334E3 - 12/31/2023, 20124334K1 - 12/31/2023, 20124334K2 - 12/31/2023, 20124334K3 - 12/31/2023, 20124334K4 - 12/31/2023, 20384334E1 01/31/2024, 20384334E2 01/31/2024, 20384334E3 10/31/2024

Quantity Affected: 82,433 cases

Reason for Recall

Acidified/Low Acid dietary supplement with no approved process.

Distribution

Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-07-12

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 30 food recalls issued in the same week, part of 204 food-related FDA actions this month.

The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls.

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 (The Procter & Gamble Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does The Procter & Gamble Company have FDA actions?

The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-1533-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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