Ultra Seal Corporation: 66 FDA recall reports
Every drug recall the FDA has published for Ultra Seal Corporation. The fault, and how the agency graded it.
66Reports
0Class I
0Ongoing
2022-02-09Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet p
D-0497-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68
- Where it went
- Nationwide within the United States
- How much
- 887,000 packets
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tab
D-0482-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
- Where it went
- Nationwide within the United States
- How much
- 5,107,565 packets
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC,
D-0506-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
- Where it went
- Nationwide within the United States
- How much
- 90,072 bottles
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 ta
D-0487-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
- Where it went
- Nationwide within the United States
- How much
- 226,400 packets
PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by:
D-0502-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
- Where it went
- Nationwide within the United States
- How much
- a)131,112 packets, b) 8,064 bottles
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. f
D-0466-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
- Where it went
- Nationwide within the United States
- How much
- 226,390 packets
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count
D-0516-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
- Where it went
- Nationwide within the United States
- How much
- a) 308,928 blisters b) 29,808 blisters
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Ad
D-0467-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
- Where it went
- Nationwide within the United States
- How much
- 1,236,000 packets
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuti
D-0473-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
- Where it went
- Nationwide within the United States
- How much
- 301,842 bottles
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b)
D-0474-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- 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 went
- Nationwide within the United States
- How much
- a) 9,060 bottles, b) 44,700 packets
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for F
D-0483-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
- Where it went
- Nationwide within the United States
- How much
- 7,858,690 packets
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet p
D-0493-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
- Where it went
- Nationwide within the United States
- How much
- 111,300 packets
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed b
D-0505-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
- Where it went
- Nationwide within the United States
- How much
- 241,560 bottles
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, M
D-0464-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
- Where it went
- Nationwide within the United States
- How much
- 3,508,200 packets
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealt
D-0477-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Where it went
- Nationwide within the United States
- How much
- 915,770 packets
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by:
D-0504-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
- Where it went
- Nationwide within the United States
- How much
- a) 156,096 packets, b) 9,648 bottles
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets,
D-0490-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
- Where it went
- Nationwide within the United States
- How much
- 2,685,700 packets
PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by:
D-0503-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
- Where it went
- Nationwide within the United States
- How much
- a) 113,040 packets, b) 7,132 bottles
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HA
D-0509-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Where it went
- Nationwide within the United States
- How much
- 223,090 packets
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine H
D-0478-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
- Where it went
- Nationwide within the United States
- How much
- 673,160 packets
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
D-0499-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
- Where it went
- Nationwide within the United States
- How much
- 533,100 packets
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. f
D-0484-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
- Where it went
- Nationwide within the United States
- How much
- 5,741,384 packets
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamid
D-0488-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
- Where it went
- Nationwide within the United States
- How much
- 1,188,280 packets
Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffe
D-0485-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
- Where it went
- Nationwide within the United States
- How much
- 1,186,000 packets
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for S
D-0519-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
- Where it went
- Nationwide within the United States
- How much
- 227,010 packets
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet
D-0468-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
- Where it went
- Nationwide within the United States
- How much
- 225,350 packets
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles,
D-0470-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
- Where it went
- Nationwide within the United States
- How much
- 174,852 bottles
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tab
D-0486-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
- Where it went
- Nationwide within the United States
- How much
- 301,650 packets
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical
D-0494-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
- Where it went
- Nationwide within the United States
- How much
- 769,200 packets
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare,
D-0475-2022 · Class II · reported 2022-02-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
- Where it went
- Nationwide within the United States
- How much
- 2,189,232 bottles
Showing the 30 most recent of 66. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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