The Recall Desk

Hazard

Chemical Impurity recalls

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

What the numbers show

Total
26
Critical
0
Severe
5
Most recent
2026-05-27

Of the 26 chemical 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 5 (19%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all chemical 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.

1–25 of 26

  • SevereFDA (Drugs)·D-0545-2026·2026-05-27

    Erythromycin 500 mg Tablets Recalled for Impurity Above Limits

    Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets nationwide due to the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit, resulting from manufacturing deviations.

    Product
    ERYTHROMYCIN — ERYTHROMYCIN (ERYTHROMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0189-2025·2025-01-15

    Duloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits

    Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0162-2025·2025-01-01

    Duloxetine antidepressant recall for chemical impurity above FDA limit

    Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0036-2025·2024-11-13

    Morphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation

    Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.

    Product
    Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2025·2024-11-06

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity

    Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0555-2024·2024-06-26

    FDA Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity Specification Failure

    Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0535-2024·2024-06-12

    FDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2024·2024-01-17

    FDA Recalls Desloratadine Tablets Due to Manufacturing Defect

    Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.

    Product
    DESLORATADINE — DESLORATADINE (DESLORATADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0907-2023·2023-07-19

    Fexofenadine Hydrochloride Tablets Recalled for Failed Purity Specifications

    L. Perrigo Company is recalling 15,504 cartons of Fexofenadine Hydrochloride 180 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·23172·2023-03-31

    The Laundress Fabric Conditioners Recalled for Ethylene Oxide Contamination

    The Laundress is recalling about 800,000 fabric conditioner products sold nationwide from 2011 through November 2022 because they may contain ethylene oxide, a chemical carcinogen. Consumers should stop using the products immediately and contact The Laundress for a refund.

    Product
    The Laundress Fabric Conditioners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1547-2022·2022-10-05

    Rifampin Capsules Recalled for Exceeding Impurity Specification Limits

    Akorn, Inc. is recalling 18,145 bottles of Rifampin Capsules, USP 150 mg due to impurity levels exceeding the FDA's 5 ppm interim specification limit for 1-Methyl-4-Nitrosopiperazine (MNP).

    Product
    Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0972-2022·2022-06-08

    Losartan Potassium tablets recalled for excessive AZIDO impurity

    Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0838-2022·2022-05-11

    Losartan Potassium tablets recalled for AZIDO impurity above limits

    Lupin Pharmaceuticals recalls Losartan Potassium tablets for CGMP deviations with AZIDO impurity above limits. The recall affects 657,336 bottles distributed nationwide; no illnesses reported.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0835-2022·2022-05-11

    Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0759-2022·2022-04-13

    Pfizer Recalls Blood Pressure Tablets Due to Manufacturing Defects

    Pfizer is recalling quinapril HCl/hydrochlorothiazide tablets due to manufacturing defects that allowed N-nitroso impurities to exceed acceptable daily intake limits. Patients taking affected lots should contact their pharmacy.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0755-2022·2022-04-13

    Pfizer Accuretic Blood Pressure Tablets Recalled for Chemical Impurity

    Pfizer is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets nationwide due to unacceptable levels of N-nitroso chemical impurities from manufacturing deviations. The affected lot includes 160 bottles.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0757-2022·2022-04-13

    Accuretic Blood Pressure Tablets Recalled for Excess Chemical Impurity

    Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for N-Nitroso Impurity

    Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0828-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recall Due to Low Sodium Levels

    Fresenius Medical Care is recalling 198 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1238-2020·2020-04-22

    Losartan Potassium Tablets Recalled Due to NBMA Impurity Detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because an impurity, NBMA, was detected in the active ingredient.

    Product
    Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1285-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1048-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 25 mg, because an impurity was detected. The recall involves 456,732 bottles distributed by Wal-Mart.

    Product
    Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0540-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems 25 mcg/h because a degradation product exceeded specification limits.

    Product
    Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2017·2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets Due to Impurities

    Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because they failed impurity specifications.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0525-2016·2015-12-30

    Perrigo Recalls Equaline All Day Allergy Tablets Due to Impurity

    Perrigo is recalling Equaline All Day Allergy tablets because they contain an impurity called cetirizine monosaccharide ester.

    Product
    EQUALINE ALL DAY ALLERGY — EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide