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.

201–225 of 458

  • SevereFDA (Drugs)·D-1866-2019·2019-09-25

    Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 3,240 cartons of Allergy Relief (fexofenadine hydrochloride) tablets because they failed impurity and degradation specifications.

    Product
    Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1867-2019·2019-09-25

    Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 71,748 bottles of Member's Mark fexofenadine hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1874-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 4,536 cartons of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1871-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine HCL Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 6,104 bottles of Fexofenadine HCL 180 mg tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1865-2019·2019-09-25

    Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

    Aurolife Pharma is recalling specific lots of Allergy Relief (Fexofenadine Hydrochloride) 180 mg tablets because they failed impurities and degradation specifications.

    Product
    Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1862-2019·2019-09-25

    Torrent Pharma Recalls Anagrelide Capsules Due to Impurity Failures

    Torrent Pharma Inc. is recalling 2,472 bottles of Anagrelide Capsules because routine stability testing detected high levels of impurities.

    Product
    ANAGRELIDE — ANAGRELIDE (ANAGRELIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1839-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1840-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Fill Volume and Impurity Issues

    Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1841-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling Eptifibatide Injection vials because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1820-2019·2019-08-21

    American Health Packaging Recalls Aspirin and Dipyridamole Capsules

    American Health Packaging is recalling specific lots of Aspirin and Extended-release Dipyridamole Capsules due to an unknown impurity found in stability samples.

    Product
    Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2019·2019-07-17

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1466-2019·2019-07-17

    Major Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Major Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1459-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1461-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2019·2019-07-17

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Losartan Potassium 100 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1465-2019·2019-07-17

    Losartan Potassium Tablets Recalled Due to NMBA Impurity Detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 100 mg tablets because an impurity called NMBA was detected in the active ingredient.

    Product
    Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2019·2019-07-17

    Losartan Potassium tablets recalled due to impurity detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2019·2019-07-17

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals USA is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1457-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1390-2019·2019-06-26

    Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures

    Sun Pharmaceutical is recalling Wal-Fex D allergy and congestion tablets because testing showed impurity levels above or near specification limits.

    Product
    Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1289-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
    Category
    Drug
    Distribution
    Distributed nationwide