The Recall Desk
HighFDA (Food)·F-1536-2022·Announced 2022-08-10

Vicks ZzzQuil Liquid Melatonin Syrup Pediatric Recalled for Unapproved Acidification Process

Procter & Gamble is recalling Vicks ZzzQuil Liquid Melatonin Syrup Pediatric because it was manufactured without FDA's approved process for acidified/low-acid dietary supplements.

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: This FDA Class II recall involves a dietary supplement manufactured without an approved acidification process, creating a theoretical food safety hazard. No illnesses or injuries have been reported. Per the rubric, recalls for risk-of-harm products without reported injury are classified as High (3).

Plain-English summary

Vicks ZzzQuil Liquid Melatonin Syrup Pediatric (8oz plastic bottles, sold individually or in twin packs) is being recalled by The Procter & Gamble Company. The product was manufactured as an acidified or low-acid dietary supplement without following FDA's approved process for such products, creating a potential food safety risk. The recalled product was distributed across 42 states.

Approximately 60,778 cases are affected by this recall. Consumers should stop using the product immediately. Specific batch and lot numbers affected are available from the FDA recall notice and directly from Procter & Gamble.

Consumers with health concerns related to product use should contact their healthcare provider. Retailers should remove affected batches from shelves immediately.

The recalled product

Product
Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as single and twin pack
Manufacturer
The Procter & Gamble Company
Hazard
  • unapproved-process

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 (20)

  • Batch Numbers: 10334334W1
  • 10334334W2
  • 11164334Y1
  • 11234334Y1
  • 11454334E1
  • 11454334E2
  • 11454334Y1
  • 11454334Y2
  • 12034334D1
  • 12164334C1
  • 12164334C2
  • 12164334D1
  • 13014334D1
  • 13014334D2
  • 13124334P1
  • 20074334K1
  • 20754334K1
  • 20754334T1
  • 20754334T2
  • 10824334R1

Distribution

Distribution scope not specified by the agency.