The Recall Desk

Manufacturer

ULTRAtab Laboratories, Inc.

43 recalls in our database name ULTRAtab Laboratories, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 43

  • ModerateFDA (Food)·F-0724-2022·2022-02-16

    Caffeine vitamin supplement recalled for manufacturing process deviations

    ULTRAtab Laboratories has recalled 1.6 million tablets of a caffeine and B-vitamin supplement due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

    Product
    Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0525-2022·2022-02-16

    Zee Cold Tabs Recalled for CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
    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 (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-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 (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 (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-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 (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-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-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-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-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-0548-2022·2022-02-16

    Acetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations

    ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.

    Product
    APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
    Category
    Drug
    Distribution
    0 states
  • 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-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-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 (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-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-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-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-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 (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-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 (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