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.

176–200 of 458

  • SevereFDA (Drugs)·D-1101-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to NMBA Impurity

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 50 mg because an impurity, NMBA, was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1100-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets because an impurity was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1258-2020·2020-04-08

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because retained sample testing showed total impurities exceeded the allowed limit.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling 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, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2020·2020-03-11

    Lupin Recalls Desoximetasone Topical Spray Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 876 bottles of Desoximetasone Topical Spray because high out-of-specification impurities were detected.

    Product
    Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0850-2020·2020-02-26

    NCS Healthcare Recalls Glycopyrrolate Tablets Due to Impurity Failure

    NCS Healthcare of Kentucky Inc is recalling 6,929 blister cards of Glycopyrrolate Tablets, USP, 1 mg, due to high out-of-specification results for an unknown impurity.

    Product
    Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0853-2020·2020-02-26

    AuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity

    AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection due to elevated levels of Benzaldehyde impurity found in investigative samples.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0661-2020·2020-01-22

    AvKARE Recalls Dutasteride Capsules Due to Impurity Specification Failures

    AvKARE Inc. is recalling specific lots of Dutasteride Capsules, 0.5 mg, because they failed impurity and degradation specifications.

    Product
    Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0660-2020·2020-01-22

    Sun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling 207,585 blisters of Sumatriptan Succinate 100 mg tablets due to failed impurity specifications.

    Product
    Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0650-2020·2020-01-15

    Enovachem Recalls Estriol USP 0.06 g Due to Impurity Failures

    Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.06 g, due to out-of-specification impurity test results.

    Product
    Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0651-2020·2020-01-15

    Enovachem Recalls Estriol USP Micronized Due to Impurity Test Failures

    Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling specific lots of Estriol, USP, (Micronized), 0.12 g, because additional testing found Out of Specification impurity test results.

    Product
    Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0652-2020·2020-01-15

    Enovachem Recalls Estriol USP Micronized 0.24 g Due to Impurity Failures

    Enovachem Pharmaceuticals is recalling Estriol USP (Micronized) 0.24 g because additional testing revealed out-of-specification impurity results.

    Product
    Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0635-2020·2020-01-08

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Specifications

    Lupin Pharmaceuticals is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution because an out-of-specification impurity was detected.

    Product
    Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0130-2020·2019-10-16

    Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure

    Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.

    Product
    Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0139-2020·2019-10-16

    Mylan Recalls Rifampin Injection Vials Due to Impurity Concerns

    Mylan Laboratories is recalling 19,165 vials of Rifampin for Injection due to elevated unknown impurities that may reduce product effectiveness.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0124-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium/Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0123-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets

    Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide tablets due to the presence of an impurity above acceptable levels.

    Product
    Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0121-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0122-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1869-2019·2019-09-25

    Aurolife Recalls Fexofenadine Tablets Due to Impurity Failures

    Aurolife Pharma is recalling equate Allergy Relief tablets because they failed impurity and degradation specifications.

    Product
    Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1868-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling specific lots of Fexofenadine Hydrochloride 180 mg tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1863-2019·2019-09-25

    West-Ward Recalls Oxcarbazepine Oral Suspension Due to Impurity Failures

    West-Ward Columbus Inc is recalling specific lots of Oxcarbazepine Oral Suspension because they failed impurity and degradation specifications.

    Product
    Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1872-2019·2019-09-25

    Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

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

    Product
    Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
    Category
    Drug
    Distribution
    Distributed nationwide