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.

4851–4875 of 21589

  • ModerateFDA (Drugs)·D-0543-2022·2022-02-16

    Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0531-2022·2022-02-16

    Acetaminophen 325 mg bulk tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.

    Product
    APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0640-2022·2022-02-16

    Natural Way Cheese Dill Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Dill Cheese Curds because milk was stored in a holding tank longer than the required 72-hour cleaning interval. The improper storage creates a potential food safety risk.

    Product
    Natural Way Cheese Dill Cheese Curds, retail 12oz plastic bag UPC 8 10056 75019 0, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0537-2022·2022-02-16

    APAP 500 mg Acetaminophen Recalled Due to CGMP Deviations

    ULTRAtab Laboratories is recalling APAP 500 mg SRC Coated tablets in bulk due to manufacturing process deviations. The company voluntarily initiated the Class II recall on January 26, 2022.

    Product
    APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0726-2022·2022-02-16

    Melatonin ER supplement recalled for manufacturing practice deviations

    ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.

    Product
    Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0552-2022·2022-02-16

    Legatrin Acetaminophen and Diphenhydramine Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Legatrin bulk tablets due to manufacturing deviations that may affect product quality and safety. The company voluntarily initiated the recall after distributing approximately 14 million tablets to three distributors.

    Product
    Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0582-2022·2022-02-16

    Medical device reference standard contaminated with bacterial species

    Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.

    Product
    KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2022·2022-02-16

    Drug recall: Kramer Novis Tusicof caplet CGMP deviations

    ULTRAtab Laboratories is recalling Kramer Novis Tusicof caplets due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 639,729 tablets distributed to three wholesalers.

    Product
    Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0540-2022·2022-02-16

    Cherry Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Cherry Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall.

    Product
    Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0721-2022·2022-02-16

    Caffeine and vitamin dietary supplement tablets recalled for manufacturing practice deviations

    ULTRAtab Laboratories recalls Ephrine Plus dietary supplement tablets due to manufacturing practice deviations. The recall involves 4,250,842 tablets distributed to bulk distributors in New York and Florida.

    Product
    Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0530-2022·2022-02-16

    Drug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations

    ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0523-2022·2022-02-16

    3-Component Cold Tabs Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0554-2022·2022-02-16

    DBI Magnums Caffeine Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 8.7 million tablets distributed to three distributors.

    Product
    DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0621-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2022·2022-02-16

    HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.

    Product
    HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0544-2022·2022-02-16

    Ephedrine 25 Guaifenesin 200 Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin 200 bulk tablets due to manufacturing practice deviations. The voluntary recall affects about 7.3 million tablets distributed to three drug wholesalers.

    Product
    Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0723-2022·2022-02-16

    Caffeine dietary supplement recalled due to manufacturing practice deviations

    ULTRAtab Laboratories' caffeine and vitamin B-complex supplement is being recalled due to cGMP (Good Manufacturing Practice) deviations. The voluntary recall affects approximately 1,904,760 tablets distributed to wholesalers.

    Product
    Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0545-2022·2022-02-16

    Phenylephrine HCl 5 mg Tablet Recall Due to CGMP Deviations

    ULTRAtab Laboratories is recalling Phenylephrine HCl 5 mg tablets in bulk containers due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 4.5 million tablets distributed to three distributors.

    Product
    Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0546-2022·2022-02-16

    Drug Recall: Phenylephrine HCl 5mg Tablets Bulk Container

    ULTRAtab Laboratories is recalling approximately 7.9 million Coated Phenylephrine HCl 5mg tablets in bulk containers due to manufacturing process deviations that may affect product quality and safety.

    Product
    Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0539-2022·2022-02-16

    Peppermint Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0727-2022·2022-02-16

    Dietary supplement melatonin recall due to manufacturing deviations

    ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.

    Product
    Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0550-2022·2022-02-16

    Pain Aid PMF Caplet Drug Recall for CGMP Deviations

    ULTRAtab Laboratories is recalling Pain Aid PMF Caplets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.6 million tablets in bulk form distributed to three distributors.

    Product
    Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0725-2022·2022-02-16

    Caffeine vitamin supplement tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is voluntarily recalling 1,393,353 caffeine supplement tablets due to manufacturing practice deviations.

    Product
    Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0547-2022·2022-02-16

    Migrenol Caplet Drug Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 990,197 tablets distributed to three distributors.

    Product
    Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0567-2022·2022-02-16

    Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits

    A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
    Category
    Medical Device
    Distribution
    Distributed nationwide