The Recall Desk
HighFDA (Food)·F-1535-2022·Announced 2022-08-10

Vicks Children's Botanicals Liquid Nighttime Recalled for Improper Processing

The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Nighttime due to manufacturing without an approved acidification process. The product's preservation safety cannot be assured.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a children's dietary supplement lacking an approved preservation process. No illnesses or injuries have been reported, but improper acidification poses a potential risk-of-harm without yet-reported injury, meeting rubric criteria for Score 3.

Plain-English summary

The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Nighttime, a 4oz liquid dietary supplement product. The product was manufactured as an acidified/low acid dietary supplement without an approved FDA process for proper preservation.

Without an approved acidification method, the product's safety and shelf stability cannot be guaranteed. Approximately 18,490 cases were distributed across 42 states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin.

Consumers who have purchased this product should stop using it and discard it. Affected batch and lot numbers are: 0240C60404, 1166C60401, 1218C60401, 1237C60401, 1321C60401, 1321C60402, 1321C604Q1, 2038C60401, 2152C60401, and 2153C60401. Product number 80338364, item UPC 323900041066.

The recalled product

Product
Vicks Children's Botanicals Liquid Nighttime 4oz plastic bottle
Manufacturer
The Procter & Gamble Company
Category
Drug — Dietary Supplement
Hazard
  • improper-processing
  • acidification-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Batch Numbers: 0240C60404
  • 1166C60401
  • 1218C60401
  • 1237C60401
  • 1321C60401
  • 1321C60402
  • 1321C604Q1
  • 2038C60401
  • 2152C60401
  • 2153C60401 Lot Numbers: 0240C60404
  • 1166C60401 05/31/2023
  • 1218C60401 07/31/2023
  • 1237C60401 07/31/2023
  • 1321C60401 10/31/2023
  • 1321C60402 10/31/2023
  • 1321C604Q1 10/31/2023
  • 2038C60401 01/31/2024
  • 2152C60401 05/31/2024
  • 2153C60401 05/31/2024

Distribution

Distribution scope not specified by the agency.

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