CLASS II Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report

MidNite Sleep Health (melatonin 1.5 mg) tablets recalled by Ultra Seal

Ultra Seal is recalling MidNite Sleep Health (melatonin 1.5 mg) tablets, distributed nationwide in the US. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 18L124, 18L125, 18L126, Exp. Date 02/2022; 19C037, 19C038, 19C039, 19C040, Exp. Date 03/2022; 19D029, 19D030, Exp. Date 04/2022; 19D031, Exp. Date 06/2022; 19G047, Exp. Date 07/2022

Quantity recalled2,189,232 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0475-2022
FDA event ID: 89464
Recalling firm: Ultra Seal, New Paltz, NY
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2022
FDA classified: 31 Jan 2022
Reported: 9 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Vitamins & OTC Supplements

Timeline

24 Jan 2022	Recall initiated by company
31 Jan 2022	Classified by FDA	+7 days
9 Feb 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP deviations

Product as listed by the FDA

MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

cGMP deviations

Which lots are affected?

Lot #: 18L124, 18L125, 18L126, Exp. Date 02/2022; 19C037, 19C038, 19C039, 19C040, Exp. Date 03/2022; 19D029, 19D030, Exp. Date 04/2022; 19D031, Exp. Date 06/2022; 19G047, Exp. Date 07/2022

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

55 other products · FDA event 89464

This product is part of a recall event; the main page for the event is Pain & Sinus Reliever Pain Reliever/Nasal Decongestant recalled.

Reported	Class	Recall	Company	Reason	Where
9 Feb 2022	CLASS II	Pain & Sinus Reliever Pain Reliever/Nasal Decongestant recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Backache & Muscle Relief (acetaminophen 250 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	MidNite Natural sleep aid Chewable Tablets Cherry Flavor recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cold Terminator decongestant/cold relief recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Peptime Energy (caffeine 300mg) tablets recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	AERO TAB Cold Relief (acetaminophen 325 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Maximum Strength Non Aspirin Pain Reliever/Fever Reducer recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Dologen (acetaminophen 325 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cold Relief (acetaminophen 250 mg, guaifenesin 200mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Painaid BRF Back Relief Formula (acetaminophen 250 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Nasal & Sinus Decongestant (phenylephrine HCl 5mg) per packet recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cetafen Non-aspirin pain reliever recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Peptime Energy (caffeine 250mg) tablets recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Dilotab II, Sinus And Cold Relief Non Drowsy recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Peptime Energy (caffeine 350mg) tablets recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Fem-prin Menstrual Relief (acetaminophen 325 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Multi Symptom Cold Relief (acetaminophen 325 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Papenol (acetaminophen 500 mg) packets recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Headache & Congestion Sinus Relief (acetaminophen 250 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Pain Terminator extra strength pain relief (aspirin 162 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Pain Away Pain Reliever/Fever Reducer (Nsaid) recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Sinus Relief Headache/Nasal (acetaminophen 325mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Chloresin (acetaminophen 325mg, dextromethorphan HBr 15mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Painaid PMF Premenstrual Formula (acetaminophen 500 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Nutralox Mint Antacid (calcium carbonate 420mg) Chewable recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Painaid (acetaminophen 110 mg, aspirin 162mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Congestaid II Nasal Decongestant (Phenylephrine HCl 5mg) packets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Lite Remfresh Advanced Ion-Powered Melatonin recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cetafen Extra Non-Aspirin Pain Relieve recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Miralac (calcium carbonate 420mg) tablets, Mint Flavor packets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Mint Flavored Antacid (Calcium Carbonate 420mg) packets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cystex Urinary Pan Relief (Nsaid) (methenamine 162mg recalledCystex	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Back Pain-Off (caffeine 50mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Extra Strength (ES) Pain Reliever (acetaminophen 500 mg) packets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Peptime Energy (caffeine 250mg) tablets recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Extra Strength Un-aspirin (acetaminophen 500 mg) 2 Caplet packets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Magnacal (calcium carbonate 420 mg) packets recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Sinu-phen Plus sinus pain and congestion tabs recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cold Relief Severe Pain/Cough (acetaminophen 325mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Aypanal Non-aspirin Pain Reliever recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Regular Strength Pain Reliever (acetaminophen 110 mg recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Sinus Decongestant Nasal Decongestant recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Cetafen Cough & Cold Cough & Cold Relief recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Electrolyte Supplement Tablets (calcium 5.2 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022	CLASS II	Multi-Symptom Cramp Relief (acetaminophen 325mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Ultra Seal

All 66

Reported	Class	Recall	Company	Reason	Where
9 Feb 2022Drug	CLASS II	Multi-Symptom Cramp Relief (acetaminophen 325mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022Drug	CLASS II	Electrolyte Supplement Tablets (calcium 5.2 mg recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022Drug	CLASS II	Cetafen Cough & Cold Cough & Cold Relief recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022Drug	CLASS II	REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
9 Feb 2022Drug	CLASS II	Sinus Decongestant Nasal Decongestant recalled by Ultra Seal	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide