Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as s...
FDA Recall #F-1536-2022 — Class II — July 12, 2022
Recall Summary
| Recall Number | F-1536-2022 |
| Date Initiated | July 12, 2022 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | The Procter & Gamble Company |
| Location | Cincinnati, OH |
Product Description
Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as single and twin pack
Reason for Recall
Acidified/Low Acid dietary supplement with no approved process.
Classification
Class II — 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.
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.
Product Quantity
60,778 cases
Product Codes / Lot Numbers
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
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.