The Recall Desk

Hazard

Assay Failure recalls

36 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
36
Critical
0
Severe
9
Most recent
2026-01-21

Of the 36 assay failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (25%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all assay failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–36 of 36

  • HighFDA (Drugs)·D-0112-2017·2016-10-26

    Supernus Recalls Trokendi XR Capsules Due to Assay Failure

    Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed to meet assay specifications.

    Product
    TROKENDI XR — TROKENDI XR (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0802-2016·2016-04-13

    Meditech Formula 2 Injection Recalled for Superpotent Drug Ingredient

    Meditech Laboratories is recalling Formula 2 Injection vials because one ingredient exceeded assay specifications, making the drug superpotent.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0033-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.

    Product
    Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0036-2016·2015-10-21

    Ohm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Up&Up loratadine tablets because they failed an assay test, potentially making them superpotent.

    Product
    Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1814-2015·2015-09-23

    Apotex Recalls Cevimeline Hydrochloride Capsules Due to Stability Failures

    Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg, because the product may not meet specification limits for assay testing.

    Product
    Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
    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
  • 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
  • ModerateFDA (Drugs)·D-0028-2015·2014-10-29

    Bio-Pharm Recalls Acetaminophen Oral Suspension Due to Assay Failure

    Bio-Pharm, Inc. is recalling one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL because the product failed the assay at the 6-month timepoint.

    Product
    Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1658-2012·2012-08-29

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1440-2012·2012-08-08

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
    Category
    Drug
    Distribution
    Distributed nationwide