The Recall Desk

Hazard

Impurity recalls

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

What the numbers show

Total
458
Critical
0
Severe
120
Most recent
2026-09-02

Of the 458 impurity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 120 (26%) 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 impurity 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.

376–400 of 458

  • ModerateFDA (Drugs)·D-0735-2016·2016-03-09

    Sun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Levels

    Sun Pharma Global Fze is recalling specific lots of Alendronate Sodium Tablets 70 mg because unknown impurity levels exceeded specifications during stability testing.

    Product
    Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 416
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2016·2016-03-02

    Zydus Recalls Risperidone Tablets Due to Impurity Failure

    Zydus Pharmaceuticals is recalling 9,504 bottles of 2 mg risperidone tablets because they failed impurity specifications. The affected lot is MP4967.

    Product
    risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0650-2016·2016-02-10

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling Clonazepam Tablets, 0.5 mg, because a known impurity exceeded specifications at the 6-month timepoint.

    Product
    Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0574-2016·2016-01-27

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 1,685 bottles of Phentermine Hydrochloride capsules because stability tests showed impurities exceeded specifications.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0566-2016·2016-01-20

    Teva Recalls Amphetamine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,717 bottles of mixed amphetamine salts tablets because stability testing revealed high impurity levels.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0564-2016·2016-01-13

    PQ Corporation Recalls Epsom Salt Bags Due to High Iron Levels

    PQ Corporation is recalling 50 lb bags of Epsom Salt because iron levels exceeded USP limits. The product was distributed in Kentucky.

    Product
    EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0231-2016·2015-11-25

    Akorn Recalls RIFAMPIN FOR INJECTION Due to Impurity Specifications

    Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet specifications.

    Product
    RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1371-2015·2015-09-02

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech is recalling specific lots of Phentermine Hydrochloride Capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1370-2015·2015-09-02

    Taro Recalls Topicort Topical Spray Due to Impurity Test Failures

    Taro Pharmaceuticals is recalling Topicort topical spray because impurity testing failed at 6 and 9 months. The recall covers 16,320 bottles distributed nationwide.

    Product
    TOPICORT — TOPICORT (DESOXIMETASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1236-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal Systems because they failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1237-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Transdermal Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling 16,504 boxes of Nitroglycerin Transdermal Systems because two lots failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1115-2015·2015-06-10

    Sandoz Recalls Cetirizine HCl Chewable Tablets Due to Impurity Failure

    Sandoz, Inc. is recalling specific lots of Cetirizine HCl Chewable Tablets because an impurity exceeded specifications during stability testing.

    Product
    Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College R
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1087-2015·2015-06-03

    Teva Recalls QVAR Inhalers Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling QVAR inhalers because stability testing revealed out-of-specification impurity results.

    Product
    QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2015·2015-05-27

    Mylan Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Levels

    Mylan Institutional, Inc. is recalling 1,363 cartons of Fexofenadine Hydrochloride 60 mg tablets because routine stability testing showed slightly above specification results for a related compound.

    Product
    Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1078-2015·2015-05-20

    Cipla Recalls Levalbuterol Inhalation Solution Vials for Impurity Failure

    Cipla Limited is recalling 140,625 vials of Levalbuterol Inhalation Solution because the product failed impurity specifications. The affected lot is distributed nationwide.

    Product
    Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0436-2015·2015-04-15

    Heritage Pharmaceuticals Recalls Gliptizide and Metformin Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling specific lots of Gliptizide and Metformin HCL tablets because they failed impurity specifications. The affected bottles were distributed nationwide.

    Product
    GLIPIZIDE AND METFORMIN HCL — GLIPIZIDE AND METFORMIN HCL (GLIPIZIDE AND METFORMIN HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0435-2015·2015-04-15

    Mylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 60 mg tablets because they failed impurity specifications. The recall covers 13,856 bottles distributed nationwide.

    Product
    Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    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-0420-2015·2015-04-01

    West-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures

    West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0409-2015·2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling 13,464 bottles of Simvastatin 80mg tablets because the product failed a known impurity specification.

    Product
    Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0408-2015·2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling Simvastatin Tablets, 40mg, because the product failed a known impurity specification. The recall affects 13,488 bottles distributed nationwide.

    Product
    Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0407-2015·2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling specific lots of Simvastatin Tablets, 20mg, because the product failed a known impurity specification.

    Product
    Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
    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