Affected lots: Batch Numbers: 10324334R1, 10324334R2, 10324334R3, 10324334R4, 10324334R5, 10324334R6,10534334R1, 10534334R2, 10564334R1, 10564334R2, 10764334R1, 11234334R1, 11234334R2, 11244334R1, 12164334N1, 12164334N2, 12864334N1, 20074334N1, 20074334S1, 20134334N1, 20134334N2, 1032C60401, 1032C60402, 1032C60403, 1053C60401, 1053C60402, 1056C60401, 1056C60402, 1076C60401, 1076C60402, 1076C60403, 1116C60410, 1123C60402, 1123C60404, 1124C60401, 1147C60401, 1216C60404, 1217C60401, 1235C60402, 1251C60403, 1251C60404, 1286C60402, 1286C60403, 1286C60404, 1286C60405, 1301C60403, 2007C60402, 2007C60403, 2007C6041, 2013C60401, 2035C60401, 2035C60402, 2080C60401, 2091C60401, 2096C60401 Lot Numbers: 10324334R1, 10324334R2, 10324334R3, 10324334R4, 10324334R5, 10324334R6, 10534334R1, 10534334R2, 10564334R1, 10564334R2, 10764334R1, 11234334R1, 11234334R2, 11244334R1, 12164334N1, 12164334N2, 12864334N1, 20074334N1, 20074334S1, 20134334N1,, 20134334N2, 1032C60401, 1032C60402, 1032C60403, 1053C60401, 1053C60402, 1056C60401, 1056C60402, 1076C60401, 1076C60402, 1076C60403, 1116C60410, 1123C60402, 1123C60404, 1124C60401, 1147C60401, 1216C60404, 1217C60401, 1235C60402, 1251C60403, 1251C60404, 1286C60402, 1286C60403, 1286C60404, 1286C60405, 1301C60403, 2007C60402, 2007C60403, 2007C6041, 2013C60401, 2035C60401, 2035C60402, 2080C60401, 2091C60401, 2096C60401 Product Number: 80358162,80349921 Item UPC: 80358162,323900040151 Case UPC: 10323900043074,10323900040158 Expiration Dates: 10324334R1 07/31/2022, 10324334R2 07/31/2022, 10324334R3 07/31/2022, 10324334R4 07/31/2022, 10324334R5 07/31/2022, 10324334R6 07/31/2022, 10534334R1 07/31/2022, 10534334R2 07/31/2022, 10564334R1 07/31/2022, 10564334R2 07/31/2022, 10764334R1 08/31/2022, 11234334R1 -10/31/2022 , 11234334R2 10/31/2022, 11244334R1 10/31/2022, 12164334N1 01/31/2023, 12164334N2 01/31/2023, 12864334N1 03/31/2023, 20074334N1 06/30/2023, 20074334S1 06/30/2023 , 20134334N1 06/30/2023, 20134334N2 06/30/2023, 1032C60401 07/31/2022, 1032C60402 07/31/2022, 1032C60403 07/31/2022, 1053C60401 07/31/2022, 1053C60402 07/31/2022, 1056C60401 07/31/2022, 1056C60402 07/31/2022, 1076C60401 08/31/2022, 1076C60402 08/31/2022, 1076C60403 08/31/2022, 1116C60410 09/30/2022, 1123C60402 10/31/2022, 1123C60404 10/31/2022, 1124C60401 10/31/2022, 1147C60401 10/31/2022, 1216C60404 01/31/2023, 1217C60401 01/31/2023, 1235C60402 01/31/2023, 1251C60403 02/28/2023, 1251C6040

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RecallFDA · Jul 12, 2022

Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic bottle sold as single and twin pack, recall F-1536-2022

Named company: The Procter & Gamble Company

Acidified/Low Acid dietary supplement with no approved process.

Affected lots: 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, 12164334

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RecallFDA · Oct 6, 2021

MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY, recall F-0729-2022

Named company: ULTRAtab Laboratories, Inc.

cGMP Deviations

Affected lots: Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050

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RecallFDA · Apr 8, 2021

Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20 minutes before bedtime. Manufactured by Natrol…

Named company: Natrol, LLC

One lot of ALA 300 mg Cap-50 were labeled at Melatonin 3 mg Tab-60.

Affected lots: Lot 2084395, Expiration DEC31 23

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RecallFDA · Jan 17, 2019

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets, recall F-1101-2019

Named company: ProThera, Inc. dba SFI USA

Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.

Affected lots: FG Lot 2018410057; Expiration Date 8/2020

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RecallFDA · Aug 17, 2018

Trader Darwin s Chewable Peppermint Flavored Melatonin Dietary Supplement Number of units per package: 100 tablets Package type: Bottle Units per case: 36, recall F-1992-2018

Named company: Church & Dwight Co

Product is misbranded. Bottles contain another product -GABA Calm Sublingual Orange tablets.

Affected lots: Lot numbers Expiration date WA80122852 January 2020 WA80124741 January 2020 WA80125793 January 2020 WA80127143 January 2020 WA80129581 January 2020 WA80129852 January 2020

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Warning letterFDA · Feb 5, 2019

Gold Crown Natural Products MARCS-CMS 566223, February 05, 2019

Named company: Gold Crown Natural Products

Melatonin supplements such as melatonin with valerian tablets prevent the death of neurons caused by beta proteins which is a toxic substance which accumulates in the brain of the patients with this…

Lot information: not specified in this record.

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