Vicks ZzzQuil Melatonin Syrup recalled for unapproved manufacturing process
Procter & Gamble is recalling 90,522 cases of Vicks ZzzQuil Liquid Melatonin Syrup due to being an acidified/low-acid dietary supplement without an FDA-approved manufacturing process.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The product is a low-acid dietary supplement lacking an FDA-approved manufacturing process. This is a risk-of-harm situation because improper processing of low-acid products can allow pathogenic growth, particularly botulism. No illnesses have been reported, but the hazard is inherent to the product category without proper process validation. FDA classified this as Class II.
Plain-English summary
Procter & Gamble is recalling approximately 90,522 cases of Vicks ZzzQuil Liquid Melatonin Syrup Adult, sold in 8-ounce plastic bottles individually or in twin packs. The recall was initiated because the product is classified as an acidified/low-acid dietary supplement that was manufactured without an FDA-approved process.
The affected product was distributed to retailers across 42 U.S. states nationwide. Batch numbers, lot codes, and expiration dates ranging from July 2022 through September 2023 are provided by the FDA to help consumers identify whether they have a recalled product.
The recalled product
- Product
- Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bottle sold as single and twin pack
- Manufacturer
- The Procter & Gamble Company
- Category
- Food — Dietary Supplement
- Affected units
- 90,522
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: 10324334R1
- 10324334R2
- 10324334R3
- 10324334R4
- 10324334R5
- 10324334R6
- 10534334R1
- 10534334R2
- 10564334R1
- 10564334R2
- 10764334R1
- 11234334R1
- 11234334R2
- 11244334R1
- 12164334N1
- 12164334N2
- 12864334N1
- 20074334N1
- 20074334S1
- 20134334N1
Distribution
Part of a larger recall action
This product is one of 5 recalled by The Procter & Gamble Company under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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