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.

2801–2825 of 3531

  • 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-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-0555-2022·2022-02-16

    Cystex Tablet Recall Due to CGMP Manufacturing Deviations

    ULTRAtab Laboratories is voluntarily recalling Cystex Tablets (Sodium Salicylate 162.5 mg, Methenamine 162 mg) in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The bulk product was distributed to 3 distributors.

    Product
    Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
    Category
    Drug
    Distribution
    0 states
  • 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 (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 (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-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 (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-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 (Drugs)·D-0534-2022·2022-02-16

    Drug Recall: Coated APAP 500 mg Caplets for CGMP Deviations

    ULTRAtab Laboratories, Inc. is recalling approximately 2 million Coated APAP 500 mg caplets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished product.

    Product
    Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
    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-0636-2022·2022-02-16

    Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling

    Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.

    Product
    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccan
    Category
    Medical Device
    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-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 (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-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 (Food)·F-0722-2022·2022-02-16

    Electrolyte Tablets Recalled by ULTRAtab Laboratories Due to Manufacturing Deviations

    ULTRAtab Laboratories has recalled approximately 26.6 million electrolyte tablets due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

    Product
    Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), 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
  • 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
  • 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 (Food)·F-0729-2022·2022-02-16

    Melatonin supplement MidNite Tablet recalled for manufacturing deviations

    ULTRAtab Laboratories voluntarily recalled MidNite Tablet melatonin supplements due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets distributed in bulk to two distributors in New York and Florida.

    Product
    MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 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-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 (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
  • 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