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.

51–75 of 458

  • ModerateFDA (Drugs)·D-0377-2025·2025-04-30

    Clomipramine Hydrochloride Capsules recalled for degradation product specification failure

    Lupin Pharmaceuticals is recalling Clomipramine Hydrochloride Capsules (25 mg) due to an unspecified degradation product detected in stability testing. The defect was identified during an 18-month long-term stability study.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2025·2025-04-23

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    The FDA is recalling Chlorpromazine Hydrochloride Tablets, 10 mg, due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above recommended limits. The affected lot was distributed nationwide.

    Product
    ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0361-2025·2025-04-16

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0308-2025·2025-04-09

    Prescription Duloxetine Capsules Recalled for Nitrosamine Impurity

    Breckenridge Pharmaceutical is recalling Duloxetine 30 mg capsules distributed nationwide due to a nitrosamine impurity above acceptable limits. Consumers should consult their doctor about their medication.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0309-2025·2025-04-09

    Prescription Antipsychotic Drug Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to a manufacturing quality deviation involving an impurity above recommended limits.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2025·2025-02-26

    Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2025·2025-02-26

    Atomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0203-2025·2025-01-22

    Prescription Drug Cardura Recalled for Specification Failures in Manufacturing

    Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0204-2025·2025-01-22

    Prescription Drug Cardura XL Recalled for Out-of-Specification Impurity

    Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0167-2025·2025-01-08

    Levothyroxine Sodium tablets recalled for impurity specification failure

    Lupin Pharmaceuticals is recalling Levothyroxine Sodium 75 mcg tablets due to out-of-specification impurities detected in stability testing. Affected lot LA01276 (expiring 07/2026) was distributed to one Ohio distributor.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0096-2025·2024-12-11

    Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0099-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled Due to Manufacturing Quality Deviation

    Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0050-2025·2024-11-27

    Guaifenesin Dextromethorphan Syrup Recalled for Failed Quality Specifications

    Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.

    Product
    Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0049-2025·2024-11-27

    Guaifenesin-Dextromethorphan Cough Syrup Recalled for Failed Impurity Specifications

    Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.

    Product
    Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2024·2024-07-24

    Cardura XL Extended Release Tablets Recalled for Failed Impurity Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets 8mg because two lots failed impurity and degradation specifications. Approximately 3,694 bottles were distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2024·2024-07-17

    Rising Pharma recalls Diflorasone Diacetate ointment for failed impurity specifications

    Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.

    Product
    DIFLORASONE DIACETATE — DIFLORASONE DIACETATE (DIFLORASONE DIACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0556-2024·2024-06-26

    Drug Recall: Eptifibatide Injection Due to Failed Degradation Specifications

    Eugia US LLC is recalling 15,500 vials of Eptifibatide injection nationwide due to failed impurities and degradation specifications. The defect involves a related substance identified as Eptifibatide dimer.

    Product
    EPTIFIBATIDE — EPTIFIBATIDE (EPTIFIBATIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2024·2024-06-12

    Rizatriptan Benzoate Tablets Recalled for Excessive N-Nitroso Impurity

    Glenmark Pharmaceuticals recalls certain Rizatriptan Benzoate tablets due to N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits. The affected lots were distributed nationwide.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2024·2024-06-12

    Prescription migraine drug recalled for manufacturing impurity above FDA limit

    Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2024·2024-05-29

    Prescription Drug Sirolimus Recalled for Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling Sirolimus 1mg tablets nationwide due to failed impurity and degradation specifications. The recall affects 1,176 bottles from lot H2200493 expiring 6/30/2025.

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