The Recall Desk

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.

51–66 of 66

  • ModerateFDA (Drugs)·D-0515-2022·2022-02-09

    Electrolyte Supplement Tablets Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling approximately 1.47 million packets of Electrolyte Supplement Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2022·2022-02-09

    Pain Away Pain Reliever/Fever Reducer Drug Recall for cGMP Deviations

    Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0489-2022·2022-02-09

    SINU-PHEN PLUS Sinus Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.

    Product
    SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2022·2022-02-09

    REMfresh Advanced Ion-Powered Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2022·2022-02-09

    CVS Health Natural Sleep Aid Chewable Tablets Recalled for Manufacturing Deviations

    CVS Health Natural Sleep Aid Chewable Tablets (melatonin 1.5mg) in cherry flavor are being recalled nationwide due to cGMP manufacturing deviations. The manufacturer, Ultra Seal Corporation, initiated the voluntary recall of 241,560 bottles.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0464-2022·2022-02-09

    Nasal & Sinus Decongestant Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant packets containing phenylephrine HCl 5mg due to current good manufacturing practice (cGMP) deviations. The recall affects 3,508,200 packets distributed nationwide.

    Product
    Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0077-2022·2021-11-03

    Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability

    Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.

    Product
    Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0070-2022·2021-11-03

    PainAway II Acetaminophen/Aspirin/Caffeine Tablets Recalled for Failed Stability

    Ultra Seal Corporation is recalling PainAway II tablets nationwide due to failed stability specifications. Testing found out-of-specification levels of Salicylic Acid, an aspirin-related compound.

    Product
    PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0076-2022·2021-11-03

    Xpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications

    Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.

    Product
    Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2022·2021-11-03

    AERO Tab Pain Reliever Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.

    Product
    AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0074-2022·2021-11-03

    North by Honeywell Pain Stopper Extra Strength tablets recalled for failed stability

    Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets nationwide because stability testing found out-of-specification results for Salicylic Acid, an aspirin-related compound.

    Product
    North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0075-2022·2021-11-03

    Advance Formula Pain Reliever tablets recalled for failed stability specifications

    Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.

    Product
    Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shippin
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0071-2022·2021-11-03

    Vica-Cet Back Pain Relief tablets recalled for stability specification failure

    Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.

    Product
    Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0072-2022·2021-11-03

    ZEE+ Painaid ESF Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).

    Product
    ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shi
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1512-2020·2020-08-26

    Ultra Seal Recalls Pain Relief Tablets Due to Stability Failures

    Ultra Seal Corporation is recalling specific lots of Pain Relief Maximum Strength tablets because they failed stability specifications for salicylic acid.

    Product
    Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1513-2020·2020-08-26

    Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

    Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

    Product
    Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
    Category
    Drug
    Distribution
    2 states