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.
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: 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
- Affected units
- 60,778
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
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.
See all 5 products in this recall →Related recalls
Same manufacturer · The Procter & Gamble Company
See all →- ModeratePsyllium Fiber Capsules Recalled Due to Illegible Labeling
FDA (Food) · 2024-02-28
- HighSecret anti-perspirant spray recalled for potential benzene contamination
FDA (Drugs) · 2024-01-24
- SevereOld Spice Anti-Perspirant Spray Recalled Due to Benzene Contamination
FDA (Drugs) · 2024-01-24
- HighSecret OUTLAST Dry Spray Antiperspirant Recalled for Benzene Contamination
FDA (Drugs) · 2024-01-24
- SevereOld Spice Sweat Defense Spray Recalled for Benzene Contamination Nationwide
FDA (Drugs) · 2024-01-24
Same hazard · unapproved process
See all →- HighRoasted garlic infused olive oil recalled over potential Clostridium botulinum contamination
FDA (Devices) · 2025-12-10
- HighBasil infused olive oil recalled over potential Clostridium botulinum contamination
FDA (Food) · 2025-12-10
- HighVicks ZzzQuil Melatonin Syrup recalled for unapproved manufacturing process
FDA (Food) · 2022-08-10
- HighVicks Children's Botanicals Recalled for Unapproved Acidification Process
FDA (Food) · 2022-08-10
- ModeratePort City Soups Thai Green Curry recalled for unapproved production process
FDA (Food) · 2022-03-23
Similar recalls
- ModerateVicks NyQuil Liquid Recalled for Incorrect Undeclared Excipients Labeling
FDA (Drugs) · 2013-09-25
- ModerateHVL Recalls Melatonin Tablets Containing Digestive Enzyme Supplement
FDA (Food) · 2015-02-18
- HighVicks Dayquil Cold & Flu Liquicaps Recalled for Packaging Defect
CPSC · 2009-12-18
- ModerateProcter & Gamble Recalls DayQuil and NyQuil Sinex Liquicaps Due to Packaging Defects
FDA (Drugs) · 2013-08-07
- ModerateProcter & Gamble Recalls Vicks NyQuil Due to Illegible Labeling
FDA (Drugs) · 2012-12-05
- HighVitafusion Kids Melatonin Recalled for Potential Metallic Mesh Presence
FDA (Food) · 2021-05-05