The Recall Desk

Hazard

Impurity Contamination recalls

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

What the numbers show

Total
15
Critical
0
Severe
7
Most recent
2026-05-13

Of the 15 impurity contamination recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (47%) 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 contamination 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.

1–15 of 15

  • ModerateFDA (Drugs)·D-0520-2026·2026-05-13

    Enalapril Maleate 20 mg tablets recalled for out-of-specification impurities

    JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2022·2022-01-12

    Cefixime 400 mg Capsules Recalled for Failed Impurities and Degradation Specifications

    RemedyRepack Inc. is recalling Cefixime 400 mg capsules distributed in Michigan and Pennsylvania due to failed impurities and degradation specifications. The affected products may not meet established quality and safety standards.

    Product
    Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0346-2022·2022-01-12

    Perrigo Fexofenadine Hydrochloride Tablets Recall for Impurity Contamination

    Perrigo Company PLC is recalling Fexofenadine Hydrochloride 60mg antihistamine tablets (100-count bottles) nationwide due to failed impurity specifications found during stability testing. The recall affects 41,472 containers distributed in the USA.

    Product
    Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0331-2022·2022-01-12

    Perrigo basic+care Fexofenadine Tablets Recall—Failed Impurity Specifications

    Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets (180 mg, 150-count bottles) distributed nationwide because impurity testing results exceeded specification limits during stability testing.

    Product
    basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0089-2022·2021-11-10

    Irbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.

    Product
    Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0801-2021·2021-09-22

    Glycopyrrolate Injection Recalled for Failed Impurities and Degradation Specifications

    Meitheal Pharmaceuticals is recalling Glycopyrrolate Injection, USP 4mg per 20mL in 20mL multi-dose vials due to failed impurities and degradation specifications. The recall affects specific lots distributed nationwide in the USA and India.

    Product
    Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0638-2021·2021-06-30

    Mephyton Phytonadione 5 mg Tablets Recall for Failed Impurity Specifications

    Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.

    Product
    Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2021·2021-06-23

    Dr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2021·2021-06-23

    Phytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification

    AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.

    Product
    Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1014-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Regular Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1016-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1026-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1027-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1024-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential Impurity Contamination

    Perrigo is recalling specific lots of Maximum Strength Acid Reducer ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1025-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
    Category
    Drug
    Distribution
    Distributed nationwide