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The Procter & Gamble Company Recall: Acidified/Low Acid dietary supplement with no approved process.

United States

TerminatedClass II

Company
The Procter & Gamble Company
Product
Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic…
Recall date
July 12, 2022
Terminated
August 15, 2024
Source
FDA

Reason for recall

Acidified/Low Acid dietary supplement with no approved process.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as single and twin pack Not published in this source record 60,778 cases Batch Numbers: 10334334W1, 10334334W2, 11164334Y1, 11234334Y1, 11454334E1, 11454334E2, 11454334Y1, 11454334Y2, 12034334D1, 12164334C1, 12164334C2, 12164334D1, 13014334D1, 13014334D2, 13124334P1, 20074334K1, 20754334K1, 20754334T1, 20754334T2, 10824334R1, 10824334R2, 10894334F1, 11234334R1, 11454334R1, 11454334R2, 12164334N1, 12164334N2, 12164334N3, 12164334N4, 12164334N5, 12164334S1, 12354334N1, 13014334N1, 13124334N1, 13414334S1, 20074334S1, 20134334S1, 20134334S2, 20754334S1, 1033C60401, 1082C60402, 1116C60408, 1116C60409, 1123C60401, 1145C060401, 1145C60402, 1145C60403, 1203C60401, 1216C60401, 1216C60402, 1235C60401, 1301C60401, 1301C60402, 1312C60403, 1312C60404, 1341C60401, 2007C60404, 2013C60402, 2075C60401, 2075C60402, 2124C60401, 2124C60402, 2124C60403. 2124C60404, 2138C60401, 1033C60401, 1082C60402, 1116C60408, 1116C60409, 1123C60401, 1145C060401, 1145C60402, 1145C60403, 1203C60401, 1216C60401, 1216C60402, 1235C60401, 1301C60401, 1301C60402, 1301C60402, 1312C60403, 1312C60404, 1341C60401, 2007C60404, 2013C60402, 2075C60401, 2075C60402, 2124C60401, 2124C60402, 2124C60403. 2124C60404, 2138C60401 Lot Numbers: 10334334W1, 10334334W2, 11164334Y1, 11234334Y1, 11454334E1, 11454334E2, 11454334Y1, 11454334Y2, 12034334D1, 12164334C1, 12164334C2, 12164334D1 13014334D1, 13014334D2, 13124334P1, 20074334K1, 20754334K1, 20754334T1, 20754334T2, 10824334R1, 10824334R2, 10894334F1, 11234334R1, 11454334R1, 11454334R2, 12164334N1, 12164334N2, 12164334N3, 12164334N4, 12164334N5, 12164334S1, 12354334N1, 13014334N1, 13124334N1, 13414334S1, 20074334S1, 20134334S1, 20134334S2, 20754334S1 Product Number: 80338887, 80358161, 80349925 Item UPC: 323900041134, 323900043060, 323900040168 Case UPC: 10323900041131, 10323900043067, 10323900040165 Expiration Dates: 10334334W1 - 7/31/2022, 10334334W2 7/31/2022, 11164334Y1 09/30/2022, 11234334Y1 10/31/2022, 11454334E1 11/30/2022, 11454334E2 11/30/2022, 11454334Y1 11/30/2022, 11454334Y2 11/30/2022, 12034334D1 12/31/2022, 12164334C1 01/31/2023, 12164334C2 01/31/2023, 12164334D1 01/31/2023, 13014334D1 03/31/2023, 13014334D2 03/31/2023, 13124334P1 04/30/2023, 20074334K1 06/30/2023, 20754334K1 08/31/2023, 20754334T1 08/31/2023, 20754334T2 08/31/2023, 10824334R1 08/31/2022, 10824334R2 08/31/2022, 10894334F1 10/31/2022, 11234334R1 10/31/2022 , 11454334R1 10/31/2022, 11454334R2 10/31/2022, 12164334N1 01/31/2023, 12164334N2 01/31/2023, 12164334N3 01/31/2023, 12164334N4 01/31/2023, 12164334N5 01/31/2023, 12164334S1 01/31/2023, 12354334N1 1/31/2023, 13014334N1 03/31/2023 , 13124334N1 04/30/2023, 13414334S1 05/31/2023, 20074334S1 06/30/2023, 20134334S1 06/30/2023, 20134334S2 06/30/2023, 20754334S1 08/31/2023, 1033C60401 07/31/2022, 1082C60402 08/31/2022, 1116C60408 09/30/2022, 1116C60409 09/30/2022, 1123C60401 10/31/2022, 1145C060401 10/31/2022, 1145C60402 10/31/2022, 1145C60403 10/31/2022, 1203C60401 12/31/2022, 1216C60401 01/31/2023, 1216C60402 01/31/2023, 1235C60401 01/31/2023, 1301C60401 03/31/2023, 1301C60402 03/31/2023, 1312C60403 04/30/2023, 1312C60404 04/30/2023, 1341C60401 05/31/2023, 2007C60404 06/30/2023, 2013C60402 06/30/2023, 2075C60401 08/31/2023, 2075C60402 08/31/2023, 2124C60401 10/31/2023, 2124C60402 10/31/2023, 2124C60403 10/31/2023. 2124C60404 10/31/2023, 2138C60401 10/31/2023

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.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1536-2022
Event ID
90615
Status
Terminated
Classification
Class II
Company
The Procter & Gamble Company
Product description
Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as single and twin pack
Quantity
60,778 cases
Reason
Acidified/Low Acid dietary supplement with no approved process.
Recall initiation date
July 12, 2022
Report date
August 10, 2022
Classification date
Not published in this source record
Termination date
August 15, 2024
Distribution pattern
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.
UPC, lot, and code information
Batch Numbers: 10334334W1, 10334334W2, 11164334Y1, 11234334Y1, 11454334E1, 11454334E2, 11454334Y1, 11454334Y2, 12034334D1, 12164334C1, 12164334C2, 12164334D1, 13014334D1, 13014334D2, 13124334P1, 20074334K1, 20754334K1, 20754334T1, 20754334T2, 10824334R1, 10824334R2, 10894334F1, 11234334R1, 11454334R1, 11454334R2, 12164334N1, 12164334N2, 12164334N3, 12164334N4, 12164334N5, 12164334S1, 12354334N1, 13014334N1, 13124334N1, 13414334S1, 20074334S1, 20134334S1, 20134334S2, 20754334S1, 1033C60401, 1082C60402, 1116C60408, 1116C60409, 1123C60401, 1145C060401, 1145C60402, 1145C60403, 1203C60401, 1216C60401, 1216C60402, 1235C60401, 1301C60401, 1301C60402, 1312C60403, 1312C60404, 1341C60401, 2007C60404, 2013C60402, 2075C60401, 2075C60402, 2124C60401, 2124C60402, 2124C60403. 2124C60404, 2138C60401, 1033C60401, 1082C60402, 1116C60408, 1116C60409, 1123C60401, 1145C060401, 1145C60402, 1145C60403, 1203C60401, 1216C60401, 1216C60402, 1235C60401, 1301C60401, 1301C60402, 1301C60402, 1312C60403, 1312C60404, 1341C60401, 2007C60404, 2013C60402, 2075C60401, 2075C60402, 2124C60401, 2124C60402, 2124C60403. 2124C60404, 2138C60401 Lot Numbers: 10334334W1, 10334334W2, 11164334Y1, 11234334Y1, 11454334E1, 11454334E2, 11454334Y1, 11454334Y2, 12034334D1, 12164334C1, 12164334C2, 12164334D1 13014334D1, 13014334D2, 13124334P1, 20074334K1, 20754334K1, 20754334T1, 20754334T2, 10824334R1, 10824334R2, 10894334F1, 11234334R1, 11454334R1, 11454334R2, 12164334N1, 12164334N2, 12164334N3, 12164334N4, 12164334N5, 12164334S1, 12354334N1, 13014334N1, 13124334N1, 13414334S1, 20074334S1, 20134334S1, 20134334S2, 20754334S1 Product Number: 80338887, 80358161, 80349925 Item UPC: 323900041134, 323900043060, 323900040168 Case UPC: 10323900041131, 10323900043067, 10323900040165 Expiration Dates: 10334334W1 - 7/31/2022, 10334334W2 7/31/2022, 11164334Y1 09/30/2022, 11234334Y1 10/31/2022, 11454334E1 11/30/2022, 11454334E2 11/30/2022, 11454334Y1 11/30/2022, 11454334Y2 11/30/2022, 12034334D1 12/31/2022, 12164334C1 01/31/2023, 12164334C2 01/31/2023, 12164334D1 01/31/2023, 13014334D1 03/31/2023, 13014334D2 03/31/2023, 13124334P1 04/30/2023, 20074334K1 06/30/2023, 20754334K1 08/31/2023, 20754334T1 08/31/2023, 20754334T2 08/31/2023, 10824334R1 08/31/2022, 10824334R2 08/31/2022, 10894334F1 10/31/2022, 11234334R1 10/31/2022 , 11454334R1 10/31/2022, 11454334R2 10/31/2022, 12164334N1 01/31/2023, 12164334N2 01/31/2023, 12164334N3 01/31/2023, 12164334N4 01/31/2023, 12164334N5 01/31/2023, 12164334S1 01/31/2023, 12354334N1 1/31/2023, 13014334N1 03/31/2023 , 13124334N1 04/30/2023, 13414334S1 05/31/2023, 20074334S1 06/30/2023, 20134334S1 06/30/2023, 20134334S2 06/30/2023, 20754334S1 08/31/2023, 1033C60401 07/31/2022, 1082C60402 08/31/2022, 1116C60408 09/30/2022, 1116C60409 09/30/2022, 1123C60401 10/31/2022, 1145C060401 10/31/2022, 1145C60402 10/31/2022, 1145C60403 10/31/2022, 1203C60401 12/31/2022, 1216C60401 01/31/2023, 1216C60402 01/31/2023, 1235C60401 01/31/2023, 1301C60401 03/31/2023, 1301C60402 03/31/2023, 1312C60403 04/30/2023, 1312C60404 04/30/2023, 1341C60401 05/31/2023, 2007C60404 06/30/2023, 2013C60402 06/30/2023, 2075C60401 08/31/2023, 2075C60402 08/31/2023, 2124C60401 10/31/2023, 2124C60402 10/31/2023, 2124C60403 10/31/2023. 2124C60404 10/31/2023, 2138C60401 10/31/2023
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
E-Mail
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Other products recalled under this same event

This recall shares FDA event ID 90615 with 4 other product entries in Public Health Trace.

FDA Recall United States Terminated Historical recordClass II

The Procter & Gamble Company

Product
Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bott…
Published
August 10, 2022
Distribution
Alaska, Alabama, Arkansas, Arizona, Cali…

View recall →

FDA Recall United States Terminated Historical recordClass II

The Procter & Gamble Company

Product
Vicks Children's Botanicals Liquid Nighttime 4oz plastic bo…
Published
August 10, 2022
Distribution
Alaska, Alabama, Arkansas, Arizona, Cali…

View recall →

FDA Recall United States Terminated Historical recordClass II

The Procter & Gamble Company

Product
Vicks Children's Botanicals Liquid Daytime 4oz plastic bott…
Published
August 10, 2022
Distribution
Alaska, Alabama, Arkansas, Arizona, Cali…

View recall →

FDA Recall United States Terminated Historical recordClass II

The Procter & Gamble Company

Product
Vicks Children's Botanicals Liquid Daytime/Nighttime Combo P…
Published
August 10, 2022
Distribution
Alaska, Alabama, Arkansas, Arizona, Cali…

View recall →

Responsible company: The Procter & Gamble Company

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Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.