The Recall Desk

Hazard

Impurities recalls

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

What the numbers show

Total
191
Critical
4
Severe
23
Most recent
2026-08-05

Of the 191 impurities recalls we have scored against our rubric, 4 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (12%) 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 impurities 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.

76–100 of 191

  • ModerateFDA (Drugs)·D-1877-2019·2019-10-02

    Preferred Pharmaceuticals Recalls Fexofenadine HCl Tablets Due to Impurities

    Preferred Pharmaceuticals is recalling 79 bottles of Fexofenadine HCl 180 mg tablets because they failed impurities and degradation specifications.

    Product
    Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1864-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 8,240 bottles of Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1565-2019·2019-08-07

    Lupin Recalls Kaitlib Fe Tablets Due to Stability Test Failures

    Lupin Pharmaceuticals is recalling Kaitlib Fe chewable tablets because long-term stability testing showed out-of-specification impurities or degradation.

    Product
    Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet o
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2019·2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities above or near specification limits.

    Product
    Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1389-2019·2019-06-26

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

    Sun Pharmaceutical is recalling Wal-Fex D 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, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1387-2019·2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities and degradation levels above or near specification limits.

    Product
    Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1391-2019·2019-06-26

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurities

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurities and degradation specifications.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1122-2019·2019-04-17

    AvKARE Recalls Telmisartan and Amlodipine Tablets Due to Impurities

    AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.

    Product
    Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1121-2019·2019-04-17

    Lupin Recalls Telmisartan and Amlodipine Tablets Due to Stability Failures

    Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.

    Product
    TELMISARTAN AND AMLODIPINE — TELMISARTAN AND AMLODIPINE (TELMISARTAN AND AMLODIPINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0993-2019·2019-03-20

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities

    Akorn, Inc. is recalling Gentamicin Sulfate Ophthalmic Solution, 0.3%, due to high out-of-specification impurities found during stability testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0517-2019·2019-03-06

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Impurity Levels

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0512-2019·2019-02-27

    Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures

    Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.

    Product
    CICLOPIROX — CICLOPIROX (CICLOPIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0506-2019·2019-02-27

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0390-2019·2019-01-30

    Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities

    Lupin Pharmaceuticals is recalling 24,180 bottles of Fluocinolone Acetonide Topical Solution due to elevated impurities.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0348-2019·2018-12-26

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.

    Product
    NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2019·2018-11-21

    Teva Recalls Alprostadil Injection Due to Impurity Testing Failures

    Teva Pharmaceuticals is recalling Alprostadil Injection vials because routine stability testing revealed out-of-specification impurities.

    Product
    Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0083-2019·2018-10-31

    Lannett Recalls Hydroxyzine Hydrochloride Syrup Due to Impurities

    Lannett Company is recalling 8,324 bottles of Hydroxyzine Hydrochloride Syrup because cleaning procedures caused out-of-specification results for unknown impurities.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1184-2018·2018-09-19

    Pfizer Recalls Argatroban Injection Vials Due to Stability Testing Failures

    Pfizer is recalling 1,580 vials of Argatroban Injection because stability testing results were out of specification at the 18-month time point.

    Product
    Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1187-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1186-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1112-2018·2018-08-29

    Mylan Recalls Diltiazem HCl Extended-release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to out-of-specification impurities.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0979-2018·2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.

    Product
    Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distribute
    Category
    Drug
    Distribution
    Distributed nationwide