The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

2876–2900 of 3531

  • ModerateFDA (Devices)·Z-0551-2022·2022-02-09

    Olympus Spiration Valve System mislabeled with incorrect model number

    Olympus Corporation is recalling 35 units of the Spiration Valve System (SVS-V9-00) due to a mislabeled patient charge label indicating model SVS-V7-00 instead. The incorrect label could confuse healthcare providers about which valve was implanted.

    Product
    Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2022·2022-02-09

    Drug Recall: PEPTIME Energy Caffeine Tablets cGMP Violations

    Ultra Seal Corporation is recalling PEPTIME Energy 300mg caffeine tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 131,112 packets and 8,064 bottles distributed across the United States.

    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.
    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-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-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-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-0497-2022·2022-02-09

    Pain & Sinus Reliever tablets recalled for manufacturing deviations

    Ultra Seal Corporation is recalling 887,000 packets of Pain & Sinus Reliever (acetaminophen/phenylephrine) tablets nationwide due to cGMP manufacturing deviations. The recalled product is identified by Lot #AK9527 with expiration date 03/2022.

    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
    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-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-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-0490-2022·2022-02-09

    DILOTAB II Sinus Cold Relief Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling DILOTAB II Sinus and Cold Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. Approximately 2.7 million packets containing acetaminophen 325 mg and phenylephrine HCl 5 mg are affected.

    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
    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-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-0461-2022·2022-02-09

    Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride delayed-release tablets because dissolution test results for the active ingredient fall below specification limits, which may affect drug effectiveness.

    Product
    DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE — DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0467-2022·2022-02-09

    Acetaminophen Pain Reliever Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling approximately 1.2 million packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2022·2022-02-09

    Drug Recall: Cold Relief Tablets Due to cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling Cold Relief tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The affected product is distributed nationwide in the United States.

    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
    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-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-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-0501-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.

    Product
    PEPTIME Energy (caffeine 250mg) tablets, 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-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 (Devices)·Z-0546-2022·2022-02-09

    Medical Device QC Kit Component Bears Incorrect Expiration Date Label

    Microbiologics Inc is recalling KWIK-STI(TM) GBS QC Set components with a mislabeled expiration date. The Lactobacillus acidophilus component was labeled 7/31/2020 instead of 7/31/2022.

    Product
    KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
    Category
    Medical Device
    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-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-0482-2022·2022-02-09

    Backache & Muscle Relief Drug Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Backache & Muscle Relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5.1 million packets distributed across the United States.

    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
    Category
    Drug
    Distribution
    Distributed nationwide