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

Dologen (acetaminophen 325 mg recalled by Ultra Seal

Ultra Seal is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, 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 #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022
Quantity recalleda) 9,060 bottles, b) 44,700 packets

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-0474-2022
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
Drug class
Pain Medication

Timeline

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

Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02

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 #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, 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 26 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.

ReportedClassRecallCompanyReasonWhere
CLASS IIPain & Sinus Reliever Pain Reliever/Nasal Decongestant recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIBackache & Muscle Relief (acetaminophen 250 mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMidNite Natural sleep aid Chewable Tablets Cherry Flavor recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICold Terminator decongestant/cold relief recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPeptime Energy (caffeine 300mg) tablets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIAERO TAB Cold Relief (acetaminophen 325 mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMaximum Strength Non Aspirin Pain Reliever/Fever Reducer recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIEphedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICold Relief (acetaminophen 250 mg, guaifenesin 200mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPainaid BRF Back Relief Formula (acetaminophen 250 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IINasal & Sinus Decongestant (phenylephrine HCl 5mg) per packet recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICetafen Non-aspirin pain reliever recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPeptime Energy (caffeine 250mg) tablets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIDilotab II, Sinus And Cold Relief Non Drowsy recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPeptime Energy (caffeine 350mg) tablets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIFem-prin Menstrual Relief (acetaminophen 325 mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMulti Symptom Cold Relief (acetaminophen 325 mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPapenol (acetaminophen 500 mg) packets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIHeadache & Congestion Sinus Relief (acetaminophen 250 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPain Terminator extra strength pain relief (aspirin 162 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPain Away Pain Reliever/Fever Reducer (Nsaid) recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IISinus Relief Headache/Nasal (acetaminophen 325mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIChloresin (acetaminophen 325mg, dextromethorphan HBr 15mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IILegatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPainaid PMF Premenstrual Formula (acetaminophen 500 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMidNite Sleep Health (melatonin 1.5 mg) tablets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IINutralox Mint Antacid (calcium carbonate 420mg) Chewable recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPainaid (acetaminophen 110 mg, aspirin 162mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICongestaid II Nasal Decongestant (Phenylephrine HCl 5mg) packets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IILite Remfresh Advanced Ion-Powered Melatonin recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIDBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICetafen Extra Non-Aspirin Pain Relieve recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMiralac (calcium carbonate 420mg) tablets, Mint Flavor packets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMint Flavored Antacid (Calcium Carbonate 420mg) packets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICystex Urinary Pan Relief (Nsaid) (methenamine 162mg recalledCystexUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIBack Pain-Off (caffeine 50mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IISinus Relief (acetaminophen 325mg, Guaifenesin 200mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIExtra Strength (ES) Pain Reliever (acetaminophen 500 mg) packets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIPeptime Energy (caffeine 250mg) tablets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIExtra Strength Un-aspirin (acetaminophen 500 mg) 2 Caplet packets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMagnacal (calcium carbonate 420 mg) packets recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIExaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IISinu-phen Plus sinus pain and congestion tabs recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICold Relief Severe Pain/Cough (acetaminophen 325mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIAypanal Non-aspirin Pain Reliever recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIRegular Strength Pain Reliever (acetaminophen 110 mg recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IISinus Decongestant Nasal Decongestant recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IICetafen Cough & Cold Cough & Cold Relief recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIElectrolyte Supplement Tablets (calcium 5.2 mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
CLASS IIMulti-Symptom Cramp Relief (acetaminophen 325mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide

More recalls from Ultra Seal

All 66
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIMulti-Symptom Cramp Relief (acetaminophen 325mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIElectrolyte Supplement Tablets (calcium 5.2 mg recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
DrugCLASS IICetafen Cough & Cold Cough & Cold Relief recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets recalledUltra SealManufacturing (CGMP) DeviationsNationwide
DrugCLASS IISinus Decongestant Nasal Decongestant recalled by Ultra SealUltra SealManufacturing (CGMP) DeviationsNationwide