The Recall Desk

Manufacturer

Qualitest Pharmaceuticals

16 recalls in our database name Qualitest Pharmaceuticals as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
3
Most recent
2015-09-09

Of the 16 recalls from Qualitest Pharmaceuticals we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (19%) are Severe.

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.

1–16 of 16

  • LowFDA (Drugs)·D-1239-2015·2015-07-22

    Qualitest Recalls HydrOXYzine Tablets Due to Unreadable Identification Codes

    Qualitest Pharmaceuticals is recalling HydrOXYzine Hydrochloride 25 mg tablets because some identification codes are unreadable.

    Product
    HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D1151-2015·2015-07-08

    Qualitest Recalls Disulfiram Tablets Due to Dissolution Failure

    Qualitest Pharmaceuticals is recalling 2,016 bottles of Disulfiram tablets because one lot failed routine stability testing for dissolution specifications.

    Product
    Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D00432-2015·2015-04-15

    Qualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity

    Qualitest Pharmaceuticals is recalling Promethazine VC with Codeine Syrup because a stability lot failed impurity specifications.

    Product
    PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0411-2015·2015-03-18

    Qualitest Recalls Promethazine DM Syrup Due to Plastic Particulates

    Qualitest Pharmaceuticals is recalling 972 bottles of Promethazine DM Syrup because plastic cap closure particulates may be present in the product.

    Product
    PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PH
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0397-2015·2015-03-11

    Qualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size

    Qualitest Pharmaceuticals is recalling 2,808 bottles of Amlodipine Besylate tablets because one lot contains oversized tablets.

    Product
    AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0331-2015·2015-01-14

    Qualitest Recalls Acetaminophen and Codeine Oral Solution Due to Impurity

    Qualitest Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate Oral Solution because they failed impurity specifications for p-Aminophenol.

    Product
    ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension because the product failed an assay test at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension due to a failure of the product assay at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0038-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling specific lots of Children's Q-PAP Acetaminophen Oral Suspension because the product failed an assay test at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1605-2014·2014-10-01

    Qualitest Recalls Subpotent Methylprednisolone Tablets Due to Stability Issues

    Qualitest Pharmaceuticals is recalling specific lots of Methylprednisolone 4 mg tablets because they may be subpotent due to a 6-month stability time point issue.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1572-2014·2014-09-10

    Qualitest Recalls Oxycodone and Acetaminophen Tablets Due to Broken Tablets

    Qualitest Pharmaceuticals is recalling 23,544 bottles of Oxycodone and Acetaminophen tablets because broken tablets were found in sealed bottles.

    Product
    OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-394-2014·2014-01-08

    Qualitest Recalls Cetirizine Hydrochloride Syrup Due to Impurity Failure

    Qualitest Pharmaceuticals is recalling 438,055 bottles of Cetirizine Hydrochloride Syrup because the product failed impurity specifications for 4-chlorobenzophenone.

    Product
    Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1037-2013·2013-09-18

    Qualitest Recalls Effervescent Potassium Chloride Tablets Due to Labeling Error

    Qualitest Pharmaceuticals is recalling 1,680 boxes of effervescent potassium chloride tablets because they may be mislabeled as a different potassium product.

    Product
    EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1036-2013·2013-09-18

    Qualitest Recalls K Effervescent Tablets Due to Labeling Mix-up

    Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets because they may be mislabeled as Potassium/Chloride Tablets.

    Product
    K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook,
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-298-2013·2013-05-01

    Qualitest Recalls Glimepiride Tablets Due to Oversized Tablet Finding

    Qualitest Pharmaceuticals is recalling 10,373 bottles of Glimepiride 2 mg tablets because one oversized tablet was found in a sealed bottle at the retail level.

    Product
    GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
    Category
    Drug
    Distribution
    Distributed nationwide