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Ultra Seal Corporation

FDA Regulatory Profile

Ultra Seal Corporation has 66 FDA recalls, 14 inspections, 1 510(k) clearance and 1 compliance action on record.

Latest recall
D-0473-2022 · Class II · Jan 24, 2022
Latest inspection
Sep 3, 2026 · VAI
Latest 510(k)
Dec 23, 2010

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls66Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections14Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0473-2022Class IIEphedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD…Jan 24, 2022
D-0483-2022Class IICold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet…Jan 24, 2022
D-0492-2022Class IIPAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet…Jan 24, 2022
D-0487-2022Class IICOLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine…Jan 24, 2022
D-0466-2022Class IIAERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet…Jan 24, 2022
D-0464-2022Class IINasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid &…Jan 24, 2022
D-0519-2022Class IISinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets…Jan 24, 2022
D-0495-2022Class IICONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical…Jan 24, 2022
D-0479-2022Class IILite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters…Jan 24, 2022
D-0498-2022Class IIRegular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide…Jan 24, 2022
D-0508-2022Class IINutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured…Jan 24, 2022
D-0515-2022Class IIELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets…Jan 24, 2022
D-0484-2022Class IIHeadache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per…Jan 24, 2022
D-0476-2022Class IIBack Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE…Jan 24, 2022
D-0518-2022Class IISinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets…Jan 24, 2022
D-0516-2022Class IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters…Jan 24, 2022
D-0490-2022Class IIDILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet…Jan 24, 2022
D-0503-2022Class IIPEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles…Jan 24, 2022
D-0468-2022Class IICHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)…Jan 24, 2022
D-0493-2022Class IIPAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg)…Jan 24, 2022

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 3, 2026New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Mar 4, 2025New Paltz, NYTobaccoNo Action Indicated (NAI)1317759
May 2, 2024New Paltz, NYFood/CosmeticsNo Action Indicated (NAI)1317759
Feb 5, 2024New Paltz, NYTobaccoNo Action Indicated (NAI)1317759
Sep 20, 2023New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Nov 19, 2021New Paltz, NYDrugsOfficial Action Indicated (OAI)1317759
Jan 22, 2020Gardiner, NYDrugsNo Action Indicated (NAI)3014482156
Jun 29, 2018New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Dec 1, 2016New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Nov 12, 2014New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Oct 7, 2013New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Nov 15, 2011New Paltz, NYFood/CosmeticsVoluntary Action Indicated (VAI)1317759
Aug 3, 2010New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759
Feb 11, 2009New Paltz, NYDrugsVoluntary Action Indicated (VAI)1317759

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1317759New Paltz, NY13Sep 3, 2026
FEI 3014482156Gardiner, NY1Jan 22, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K101522ULTRA SEAL STERILE LUBRICATING JELLYDec 23, 2010

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.