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.

101–125 of 458

  • ModerateFDA (Drugs)·D-0910-2023·2023-07-19

    FDA Recalls Fexofenadine Allergy Relief Tablets Due to Impurity and Degradation Issues

    Target's store-brand fexofenadine allergy relief tablets are being recalled nationwide due to failed quality specifications for impurities and degradation. Consumers should stop using affected lots and contact Target or their healthcare provider.

    Product
    allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0871-2023·2023-06-21

    Tranexamic Acid Tablets Recalled for Failed Manufacturing Specifications

    Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0765-2023·2023-05-31

    Pain Reliever Caplets Recalled Due to Out-of-Specification Impurity

    Aurobindo Pharma is recalling 87,360 bottles of Pain Reliever Acetaminophen caplets (500 mg) distributed nationwide through Walgreens due to failed impurity specifications discovered through customer complaints about discoloration.

    Product
    PAIN RELIEVER — PAIN RELIEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0544-2023·2023-05-03

    DuPont Recalls Avicel PH-101 Microcrystalline Cellulose for Out-of-Specification Conductivity

    DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.

    Product
    Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0529-2023·2023-04-19

    Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification

    Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.

    Product
    NOREPINEPHRINE BITARTRATE — NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2023·2023-04-12

    Montelukast Sodium Oral Granules Recalled for Failed Impurity Specifications

    Teva is recalling Montelukast Sodium Oral Granules 4 mg (lot 3007556A) due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.

    Product
    Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0469-2023·2023-03-22

    Eye allergy medication recalled for out-of-specification impurity

    Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.

    Product
    Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 67
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0466-2023·2023-03-22

    Buprenorphine Transdermal System 20 mcg/hour Recalled for Specification Failure

    AVEVA Drug Delivery Systems recalls Buprenorphine Transdermal System 20 mcg/hour (Lot 51836) nationwide due to degradation product impurity exceeding specification limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0467-2023·2023-03-22

    FDA Recalls Colchicine Tablets Due to Failed Impurity Specifications

    Zydus Pharmaceuticals is recalling certain batches of Colchicine Tablets 0.6 mg because quality testing detected out-of-specification levels of Beta-lumicolchicine impurity. Affected lots were distributed in Arizona, Ohio, and Mississippi.

    Product
    Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 7
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0352-2023·2023-03-08

    Microcrystalline Cellulose Pharmaceutical Excipient Recalled for Specification Failure

    DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.

    Product
    BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0268-2023·2023-02-15

    Posaconazole Antifungal Tablets Recalled for Degradation Impurities

    Biocon Pharma Inc. is recalling Posaconazole Delayed-Release Tablets due to failed degradation specifications and out-of-specification impurities that may compromise medication safety and efficacy.

    Product
    POSACONAZOLE — POSACONAZOLE (POSACONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because the medication failed quality testing for impurity and degradation specifications. The recall affects 20,040 bottles.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because certain lots failed impurity and degradation quality specifications. Consumers taking affected lots should consult their pharmacist or physician.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0011-2023·2022-10-26

    Rifampin Capsules recalled due to excessive impurity levels

    Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, because samples exceeded acceptable limits for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Multiple lot numbers were distributed nationwide.

    Product
    Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1548-2022·2022-10-05

    Akorn Rifampin Capsules Recalled for Impurity Specification Failure

    Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.

    Product
    Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1351-2022·2022-08-24

    Prescription cancer drug lot recalled for failed quality specifications

    Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.

    Product
    FULVESTRANT — FULVESTRANT (FULVESTRANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1153-2022·2022-06-29

    Testosterone Cypionate Injectable Recalled for Manufacturing Quality Issues

    Sun Pharmaceutical recalls 97,450 vials of Testosterone Cypionate Injection nationwide due to manufacturing deviations that could cause out-of-specification impurities.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0988-2022·2022-06-15

    FDA Recalls Teva Alprostadil Injection for Failed Impurity Specifications

    Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.

    Product
    Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0895-2022·2022-06-01

    Blood pressure medication Losartan and hydrochlorothiazide recalled for elevated azido impurity

    Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0861-2022·2022-05-18

    Esomeprazole Magnesium Delayed-Release Capsules Recalled for Failed Quality Specifications

    Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Impurity

    Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablets nationwide due to AZIDO impurity levels above acceptable limits. Patients should consult their healthcare provider about their medication.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0774-2022·2022-04-27

    Injectable Rifampin Recalled Due to Failed Quality Specifications

    Mylan Pharmaceuticals is recalling injectable Rifampin vials nationwide due to failed impurities and degradation specifications discovered during stability testing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2022·2022-04-13

    Quinapril and Hydrochlorothiazide Tablets Recalled for Elevated Chemical Impurity

    Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0716-2022·2022-02-23

    Erythromycin Topical Gel Recalled for Failed Impurity Specifications

    Teligent Pharma is recalling one lot of Erythromycin Topical Gel USP 2% because the product failed to meet specifications for unknown maximum related compounds.

    Product
    Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0356-2022·2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
    Category
    Drug
    Distribution
    Distributed nationwide