Manufacturer

Ultra Seal Corporation

66 recalls in our database name Ultra Seal Corporation as the manufacturing or recalling firm.

What the numbers show

Total: 66
Critical: 0
Severe: 0
Most recent: 2022-02-09

Of the 66 recalls from Ultra Seal Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 66

ModerateFDA (Drugs)·D-0473-2022·2022-02-09
Ephedrine Plus tablets recalled for cGMP manufacturing deviations
Ultra Seal Corporation is recalling Ephedrine Plus tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 301,842 bottles distributed across the United States.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0474-2022·2022-02-09
Drug Recall: Dologen Caplets for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations during manufacture.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2022·2022-02-09
Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2022·2022-02-09
Drug Recall: PEPTIME Energy Tablets cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 250mg) tablets distributed nationwide due to manufacturing practice deviations. The recall affects 156,096 packets and 9,648 bottles.
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.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0478-2022·2022-02-09
Multi Symptom Cold Relief tablets recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling 673,160 packets of Multi Symptom Cold Relief tablets distributed nationwide due to cGMP (current Good Manufacturing Practice) 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2022·2022-02-09
PAPENOL acetaminophen 500 mg packets recalled for cGMP deviations
Ultra Seal Corporation is recalling PAPENOL acetaminophen 500 mg (2 tablet packets) nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 533,100 packets with lot numbers K9495 (exp. 02/2022) and AK9614 (exp. 05/2022).
Product
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2022·2022-02-09
Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations
Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0488-2022·2022-02-09
Pain Terminator Extra Strength Pain Relief Drug Recall
Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0519-2022·2022-02-09
Sinus Relief Headache/Nasal Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) nationwide due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing.
Product
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0470-2022·2022-02-09
Legatrin PM Pain Reliever/Sleep Aid Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 174,852 bottles of Legatrin PM Pain Reliever/Sleep Aid nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated on January 24, 2022.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2022·2022-02-09
Cold/Sinus Medication Recalled for Manufacturing Process Violations
Ultra Seal Corporation is recalling 301,650 packets of a Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant due to cGMP deviations discovered during manufacturing. The product was distributed nationwide.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0494-2022·2022-02-09
PAINAID PMF Premenstrual Formula Recalled for cGMP Deviations
Ultra Seal Corporation voluntarily recalled PAINAID PMF Premenstrual Formula packets nationwide due to cGMP (current Good Manufacturing Practice) 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0492-2022·2022-02-09
Drug Recall: PAINAID Tablets for Manufacturing Deviations
Ultra Seal Corporation is recalling approximately 2.3 million packets of PAINAID pain relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations in manufacturing processes.
Product
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2022·2022-02-09
Drug Recall: CONGESTAID II Nasal Decongestant for Manufacturing Deviations
Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant packets due to current Good Manufacturing Practice (cGMP) deviations. The voluntary nationwide recall affects 447,050 packets.
Product
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0511-2022·2022-02-09
CETAFEN Extra Acetaminophen 500 mg caplets recalled for manufacturing deviations
Ultra Seal Corporation is recalling CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets in 2-count packets nationwide due to current good manufacturing practice (cGMP) deviations.
Product
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0514-2022·2022-02-09
MIRALAC Calcium Carbonate Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MIRALAC calcium carbonate 420mg tablets in mint flavor due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 409,890 packets distributed nationwide.
Product
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0496-2022·2022-02-09
Mint Flavored Antacid Recalled for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling 1,309,800 packets of Mint Flavored Antacid (Calcium Carbonate 420mg) distributed nationwide due to cGMP deviations. The recall is voluntary and applies to specific lot numbers with expiration dates in 2022.
Product
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0471-2022·2022-02-09
CYSTEX Urinary Pain Relief tablets recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling CYSTEX Urinary Pain Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects specific lot numbers distributed in 40-count and 20-count blister packages.
Product
CYSTEX — CYSTEX (METHENAMINE, SODIUM SALICYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0518-2022·2022-02-09
Sinus Relief Drug Recall for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Sinus Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. Affected lots are AK9651 (exp. 06/2022) and AK9437 (exp. 01/2022).
Product
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2022·2022-02-09
Magnacal Calcium Carbonate Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MAGNACAL calcium carbonate 420 mg tablets (Lot #AK9768, expiration 08/2022) nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated on January 24, 2022.
Product
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0480-2022·2022-02-09
Cold Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling 227,010 packets of Cold Relief Severe Pain/Cough due to cGMP deviations. The recall affects Lot #AK9436 (expiration 01/2022) distributed nationwide.
Product
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0512-2022·2022-02-09
AYPANAL Pain Reliever Tablets Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling AYPANAL Non-aspirin Pain Reliever tablets (acetaminophen 325 mg) in 2-count packets nationwide due to Current Good Manufacturing Practice (cGMP) deviations.
Product
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0498-2022·2022-02-09
Regular Strength Pain Reliever recalled for cGMP deviations
Ultra Seal Corporation is recalling approximately 1.18 million packets of Regular Strength Pain Reliever nationwide due to current good manufacturing practice (cGMP) deviations.
Product
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0517-2022·2022-02-09
REMfresh Melatonin Caplets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5 mg caplets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects approximately 40,344 blisters of the product.
Product
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0510-2022·2022-02-09
Cough & Cold Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold coated tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects Lot #AK9841 with expiration date 10/2022.
Product
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Category
Drug
Distribution
Distributed nationwide