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.

426–450 of 458

  • LowFDA (Drugs)·D-1190-2014·2014-04-09

    Teva Recalls QVAR Inhalers Due to Impurity Specification Failures

    Teva Pharmaceuticals is recalling specific lots of QVAR inhalation aerosol because they failed impurity specifications during stability testing.

    Product
    QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1155-2014·2014-03-19

    Mylan Recalls Carisoprodol Tablets Due to Failed Impurity Specification

    Mylan Institutional, Inc. is recalling 3,252 cartons of Carisoprodol Tablets, USP, 350 mg, because the product failed an impurity or degradation specification.

    Product
    Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-408-2014·2014-01-22

    Lupin Recalls Quinapril Tablets Due to Unknown Impurity

    Lupin Pharmaceuticals is recalling Quinapril tablets because an unknown impurity exceeded specification limits during stability testing.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    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
  • LowFDA (Drugs)·D-379-2014·2013-12-25

    Fresenius Kabi Recalls Folic Acid Injection Vials for Impurity Failures

    Fresenius Kabi USA is recalling folic acid injection vials due to failed impurity and degradation specifications at 14 and 15 months.

    Product
    FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-346-2014·2013-12-18

    Lupin Recalls Ethambutol Hydrochloride Tablets Due to Impurity

    Lupin Pharmaceuticals is recalling 4,896 bottles of Ethambutol Hydrochloride 400 mg tablets because of an out-of-specification impurity result.

    Product
    ETHAMBUTOL HYDROCHLORIDE — ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-913-2013·2013-08-28

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Test Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity and degradation specifications. The affected product is distributed nationwide.

    Product
    Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-853-2013·2013-08-14

    West-Ward Recalls Lisinopril Tablets Due to Impurity Test Failures

    West-Ward Pharmaceutical Corp. is recalling 51,704 bottles of Lisinopril Tablets, USP, 2.5 mg because they failed impurity specifications at the 48-month time point.

    Product
    Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-829-2013·2013-08-07

    Actavis Recalls Ranitidine Syrup Due to Impurity Specification Failure

    Actavis South Atlantic LLC is recalling 133,968 bottles of Ranitidine Syrup because the product failed an impurity specification for 'Related Compound C'.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-689-2013·2013-07-17

    Teva Recalls Errin Norethindrone Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Errin (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-684-2013·2013-07-17

    Teva Recalls Balziva Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Balziva (norethindrone and ethinyl estradiol) tablets because an impurity was detected during testing.

    Product
    BALZIVA — BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-690-2013·2013-07-17

    Teva Recalls Camila Norethindrone Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Camila (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-683-2013·2013-07-17

    Teva Recalls Jolessa Birth Control Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling specific lots of Jolessa birth control tablets because an impurity was detected during testing.

    Product
    JOLESSA — JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-691-2013·2013-07-17

    West-ward Recalls Nicardipine Hydrochloride Injection Due to Impurity

    West-ward Pharmaceutical Corp. is recalling specific lots of Nicardipine Hydrochloride Injection because they failed impurity specifications for a degradation product.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-681-2013·2013-07-17

    Teva Recalls Lessina Oral Contraceptives Due to Impurity Detection

    Teva Pharmaceuticals is recalling Lessina oral contraceptives because an impurity was detected during testing. The FDA classifies this as a Class III recall.

    Product
    LESSINA — LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-605-2013·2013-06-26

    Sagent Recalls Vecuronium Bromide Injection Due to Manufacturing Deviations

    Sagent Pharmaceuticals is recalling Vecuronium Bromide for Injection because it was not manufactured under current good manufacturing practices, resulting in failed impurity specifications.

    Product
    VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-496-2013·2013-06-05

    Teva Recalls Seasonale Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Seasonale tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.

    Product
    Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-241-2013·2013-04-10

    Fougera Recalls Ketoconazole Cream 2% Due to Unknown Degradant

    Fougera Pharmaceuticals is voluntarily recalling 60,210 units of Ketoconazole Cream 2% because an unknown degradant failed impurity specifications.

    Product
    KETOCONAZOLE — KETOCONAZOLE (KETOCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-203-2013·2013-03-27

    Watson Recalls Meprobamate Tablets Due to Impurity Specification Failure

    Watson Laboratories is recalling meprobamate 200 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

    Product
    Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-204-2013·2013-03-27

    Watson Recalls Meprobamate Tablets Due to Impurity Failure

    Watson Laboratories is recalling meprobamate 400 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

    Product
    Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-126-2013·2013-01-23

    Boehringer Ingelheim Recalls Perindopril Erbumine Tablets Due to Impurity

    Boehringer Ingelheim Roxane Inc. is recalling 3,553 bottles of Perindopril Erbumine Tablets, 8mg, because out-of-specification results were found for impurity B.

    Product
    Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-128-2013·2013-01-23

    Teva Recalls Cabergoline Tablets Due to Impurity Specification Failure

    Teva Pharmaceuticals is recalling 13,232 bottles of Cabergoline 0.5 mg tablets because the product may not meet impurity specifications over its shelf life.

    Product
    CABERGOLINE — CABERGOLINE (CABERGOLINE)
    Category
    Drug
    Distribution
    Distributed nationwide