The Recall Desk

Manufacturer

ULTRAtab Laboratories, Inc.

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

What the numbers show

Total
43
Critical
0
Severe
0
Most recent
2022-02-16

Of the 43 recalls from ULTRAtab Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

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.

26–43 of 43

  • 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-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-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-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-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 (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-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 (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-0549-2022·2022-02-16

    Normed Fem Tablet Recalled Due to CGMP Deviations

    ULTRAtab Laboratories, Inc. is recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors who may have distributed finished product.

    Product
    Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
    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-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-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-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-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 (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-0542-2022·2022-02-16

    Spearmint Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.

    Product
    Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
    Category
    Drug
    Distribution
    0 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 (Drugs)·D-0327-2022·2022-01-12

    Pain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures

    ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.

    Product
    PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
    Category
    Drug
    Distribution
    0 states