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.

4876–4900 of 21589

  • ModerateFDA (Drugs)·D-0528-2022·2022-02-16

    Drug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations

    ULTRAtab Laboratories is recalling Coated APAP 325 mg Phenylephrine HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects bulk product distributed to three distributors.

    Product
    Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0529-2022·2022-02-16

    APAP 325 mg/Phenylephrine HCl 5 mg Tablets Bulk Container Recall

    ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.

    Product
    APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0532-2022·2022-02-16

    Acetaminophen 325 mg Tablets Recalled Due to Manufacturing Deviations

    ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.

    Product
    Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0533-2022·2022-02-16

    Drug Recall: Normed APAP 325 mg Acetaminophen Bulk Tablets

    ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.

    Product
    Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0728-2022·2022-02-16

    Melatonin ER supplement recalled for manufacturing practice deviations

    ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.

    Product
    Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0524-2022·2022-02-16

    Cold Tabs Drug Recalled for CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling 4-Component Cold Tabs in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed to three distributors.

    Product
    4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0527-2022·2022-02-16

    Dologen 325 Caplet Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were distributed to three distributors.

    Product
    Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0535-2022·2022-02-16

    Extra-Strength Unaspirin Caplet Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 6.2 million tablets distributed to three distributors.

    Product
    Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0536-2022·2022-02-16

    Acetaminophen 500 mg tablets recalled for CGMP deviations

    ULTRAtab Laboratories is recalling approximately 6.2 million acetaminophen 500 mg tablets due to current good manufacturing practice (CGMP) deviations. The recall is voluntary and was initiated by the manufacturer.

    Product
    APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0551-2022·2022-02-16

    Back Relief II Drug Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.

    Product
    Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0553-2022·2022-02-16

    Drug Recall: Coated Back Relief Tablet CGMP Deviations

    ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.

    Product
    Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0541-2022·2022-02-16

    Trial Antacid Tablet bulk containers recalled for CGMP deviations

    ULTRAtab Laboratories is recalling Trial Antacid Tablet bulk containers (Calcium Carbonate 420 mg) due to CGMP deviations. The product was distributed to three distributors who may have distributed finished product.

    Product
    Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0637-2022·2022-02-16

    LYSO Disk microorganism culture device mislabeled with incorrect strain

    Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.

    Product
    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
    Category
    Medical Device
    Distribution
    0 states
  • ModerateCPSC·22084·2022-02-16

    Scarves Recalled for Flammability Standard Violation and Burn Risk

    In-Things Corporation is recalling about 200 "Sparkle Sheer Social Wrap" scarves sold online because they fail to meet federal flammability standards for textiles, posing a burn injury risk.

    Product
    Scarves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22085·2022-02-16

    Anecdote Autumn Glass Candles recalled for fire and laceration hazards

    Anecdote Candles is recalling approximately 19,380 Autumn Glass Candles sold at Anthropologie because the double-wick candles can produce higher-than-normal flames, causing the glass container to break and posing fire and laceration hazards.

    Product
    Anecdote Autumn Glass Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22720·2022-02-10

    Ski-Doo 2022 Snowmobiles Recalled Due to Speedometer Crash Hazard

    BRP is recalling approximately 400 Ski-Doo 2022 snowmobiles because the speedometer may display half the vehicle's true speed, creating a crash hazard. Consumers should stop using the recalled snowmobiles and contact a Ski-Doo dealer for free repair.

    Product
    Ski-Doo Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·22723·2022-02-10

    Shop LC Electric Space Heaters Recalled Due to Fire and Burn Hazards

    Shop LC is recalling about 4,500 personal electric space heaters that can overheat, posing fire and burn hazards. Consumers should stop using them immediately and return the product for a refund.

    Product
    Personal Electric Space Heaters
    Category
    Consumer Product
    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
  • ModerateCPSC·22074·2022-02-09

    Stance Kids Crew Socks Recalled Due to Choking Hazard

    Stance is recalling about 10,800 Kids Reiny Szn Mid-Cushion Crew Socks because bells attached to the socks can detach, posing choking and aspiration hazards to young children.

    Product
    Kids Reiny Szn Mid-Cushion Crew Socks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0465-2022·2022-02-09

    Cold Tablet with Acetaminophen Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant packets due to cGMP (current Good Manufacturing Practice) deviations. Approximately 313,000 packets of Lot #K9824 (Exp. Date 09/2022) distributed nationwide are affected.

    Product
    Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
    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-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 (Devices)·Z-0558-2022·2022-02-09

    Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed

    Celltrion USA Inc. is recalling 162,000 units of the European version of its DiaTrust COVID-19 Ag Rapid Test, which was not approved for U.S. distribution. The test packaging and labeling differ from the FDA-approved U.S. version.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
    Category
    Medical Device
    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