The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 283 (18%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all cgmp deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

651–675 of 1552

  • 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-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-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-0509-2022·2022-02-09

    Drug Recall: FEM-PRIN Menstrual Relief Tablets for cGMP Deviations

    Ultra Seal Corporation is recalling FEM-PRIN Menstrual Relief tablets (223,090 packets) distributed nationwide due to cGMP deviations. The recall was voluntary and initiated on January 24, 2022.

    Product
    FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2022·2022-02-09

    Drug recall: MidNite Sleep Health melatonin tablets, cGMP deviations

    Ultra Seal Corporation is voluntarily recalling MidNite Sleep Health melatonin tablets nationwide due to current good manufacturing practice (cGMP) deviations. Approximately 2.2 million bottles are affected.

    Product
    MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0476-2022·2022-02-09

    Drug Recall: Back Pain-Off Tablets Over cGMP Violations

    Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.

    Product
    Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
    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-0469-2022·2022-02-09

    Extra Strength Pain Reliever Acetaminophen Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.

    Product
    Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2022·2022-02-09

    Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations

    Ultra Seal Corporation has voluntarily recalled 1,694,200 packets of Extra Strength Un-Aspirin (acetaminophen 500 mg) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
    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-0479-2022·2022-02-09

    Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Lite Remfresh Advanced Ion-Powered Melatonin 0.5mg tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects 25,776 blisters in lots 19E058A and 19E058B with an expiration date of May 2022.

    Product
    Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2022·2022-02-09

    Cold Terminator decongestant recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 packets distributed nationwide.

    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
    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
  • 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-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-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-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-0507-2022·2022-02-09

    Exaprin Pain Reliever Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Exaprin pain reliever tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects approximately 1.14 million packets distributed across the United States.

    Product
    Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
    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-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-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-0503-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets due to cGMP (current good manufacturing practice) deviations. The recall affects 113,040 packets and 7,132 bottles distributed nationwide.

    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.
    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