The Recall Desk

Manufacturer

Hi-Tech Pharmacal Co., Inc.

10 recalls in our database name Hi-Tech Pharmacal Co., Inc. as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
1
Most recent
2016-12-28

Of the 10 recalls from Hi-Tech Pharmacal Co., Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (10%) 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.

1–10 of 10

  • LowFDA (Food)·F-0817-2017·2016-12-28

    Hi-Tech Pharmacal Recalls Liquid Vitamin C Due to pH Issues

    Hi-Tech Pharmacal is recalling Rx CHOICE brand Liquid Vitamin C because the product failed to meet pH specifications.

    Product
    Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
    Category
    Drug
    Distribution
    16 states
  • LowFDA (Food)·F-0820-2017·2016-12-28

    Hi-Tech Pharmacal Recalls Liquid Vitamin C Due to Low Active Ingredient

    Hi-Tech Pharmacal is recalling Rx CHOICE brand Liquid Vitamin C because the active ingredient is at a lower level than stated on the label.

    Product
    Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
    Category
    Drug
    Distribution
    13 states
  • ModerateFDA (Food)·F-1380-2015·2015-03-11

    Hi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues

    Hi-Tech Pharmacal is recalling 581 units of Ferrous Sulfate Elixir because stability testing showed out-of-specification pH results.

    Product
    FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0048-2015·2014-11-05

    Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity

    Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-389-2014·2014-01-01

    Hi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures

    Hi-Tech Pharmacal is recalling Acyclovir Oral Suspension because the product's viscosity and pH levels fell below required specifications.

    Product
    Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66207-001·2013-10-30

    Hi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines

    Hi-Tech Pharmacal is recalling specific lots of Giltuss and Exactuss cough and cold medicines because they contain less phenylephrine than labeled.

    Product
    GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 0071
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-888-2013·2013-08-21

    Hi-Tech Pharmacal Recalls Clobetasol Propionate Cream Due to Labeling Error

    Hi-Tech Pharmacal is recalling Clobetasol Propionate Cream because some cartons contain tubes with gel labels. The actual product inside is the correct cream.

    Product
    Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-603-2013·2013-06-26

    Hi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution

    Hi-Tech Pharmacal is recalling specific lots of HydrOXYzine Hydrochloride Oral Solution because the product failed stability testing and may be subpotent.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-418-2013·2013-05-22

    Hi-Tech Pharmacal Recalls Subpotent Bucalsep Oral Solution

    Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution because the cetylpyridinium chloride ingredient is subpotent.

    Product
    BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-302-2013·2013-05-08

    Hi-Tech Pharmacal Recalls Subpotent Acetic Acid Otic Solution

    Hi-Tech Pharmacal is recalling 11,472 bottles of Acetic Acid Otic Solution because the product failed potency testing. The recall covers nationwide distribution and Puerto Rico.

    Product
    Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
    Category
    Drug
    Distribution
    Distributed nationwide