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.

26–50 of 191

  • HighFDA (Drugs)·D-0463-2024·2024-05-01

    GloStrips ophthalmic drug recalled for active ingredient impurities

    Nomax Inc is recalling GloStrips fluorescein sodium ophthalmic strips nationwide due to failure of the active pharmaceutical ingredient to meet USP standards for unspecified impurities.

    Product
    GLOSTRIPS — GLOSTRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2024·2024-02-28

    FDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities

    Amneal Pharmaceuticals is recalling 46,037 bottles of Oseltamivir Phosphate Oral Suspension due to failed quality test results showing impurities and degradation. The FDA classified this as a Class II recall affecting nationwide distribution.

    Product
    OSELTAMIVIR PHOSPHATE — OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0320-2024·2024-02-14

    Hydralazine Hydrochloride Tablets Recalled Due to Failed Purity Tests

    Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.

    Product
    HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0274-2024·2024-02-07

    Lupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications

    Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension 100mg/5mL (4,608 bottles) due to failed impurity and degradation specifications. The product was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2024·2023-12-20

    Liothyronine Sodium tablets recalled due to failed impurity and degradation specifications

    Sun Pharmaceutical is recalling 96,192 bottles of Liothyronine Sodium Tablets nationwide due to failed quality specifications for impurities and degradation. The affected lots were distributed in 100-count bottles.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0142-2024·2023-12-13

    Children's Acetaminophen Suspension Recalled for Failed Impurity Specifications

    KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.

    Product
    PAIN AND FEVER — PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0911-2023·2023-07-19

    Fexofenadine Tablets Recalled for Failed Impurity and Degradation Specifications

    L. Perrigo Company is recalling Picnic Fexofenadine Hydrochloride Tablets (180 mg) nationwide because the product failed impurity and degradation specifications. The affected lot is 2DR0471 with expiration date 12/23.

    Product
    Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0908-2023·2023-07-19

    Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications

    L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.

    Product
    GOOD SENSE ALLER EASE — GOOD SENSE ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0900-2023·2023-07-19

    BASIC CARE Allergy Tablets Recalled Due to Failed Quality Specifications

    BASIC CARE ALLERGY (fexofenadine hydrochloride) 180 mg tablets are being recalled nationwide due to failed impurities and product degradation specifications. Approximately 11,904 cartons were affected.

    Product
    BASIC CARE ALLERGY — BASIC CARE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0903-2023·2023-07-19

    Allergy Relief Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications

    CVS Pharmacy is recalling 16,200 cartons of Allergy Relief fexofenadine hydrochloride tablets nationwide due to failed impurities and degradation specifications. Stop using affected lot 2DV1925 and consult a pharmacist.

    Product
    Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2023·2023-06-21

    Tranexamic Acid tablets recalled due to failed specification testing

    AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2023·2023-05-24

    Lorazepam injection vials recalled for elevated impurities and degradation

    Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0562-2023·2023-05-10

    Seatex Alcohol Antiseptic 80% Hand Sanitizer Recalled for Superpotency and Impurities

    Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.

    Product
    Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0350-2023·2023-03-08

    DuPont Avicel PH-102 Microcrystalline Cellulose Recalled for Conductivity Specification Failure

    DuPont Nutrition USA is recalling Avicel PH-102 NF microcrystalline cellulose excipient due to failed conductivity specifications indicating potential impurities. The product was distributed nationwide and internationally.

    Product
    Avicel PH- 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, Cope
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0349-2023·2023-03-08

    Microcrystalline Cellulose Ingredient Recalled Over Failed Impurity Specifications

    DuPont Nutrition USA, Inc. is recalling certain batches of Avicel PH-101 microcrystalline cellulose because it failed quality testing for impurities and degradation. The ingredient showed out-of-specification conductivity levels.

    Product
    Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Cope
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0328-2023·2023-02-22

    Prescription Bupropion Hydrochloride Tablets Recalled for Failed Quality Specifications

    Amerisource Health Services LLC is recalling 1,416 cartons of Bupropion Hydrochloride Tablets (75 mg) nationwide due to failed impurities and degradation specifications. The tablets do not meet FDA quality standards for purity.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2023·2023-01-18

    Rifampin Capsules Recalled Due to Failed Quality Specifications

    RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, due to failed impurities and degradation specifications. The affected product was distributed to a single pharmacy account in Pennsylvania.

    Product
    Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0100-2023·2023-01-18

    Prescription Rifampin Capsules Recalled for Failed Impurity Specifications

    Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0087-2023·2022-12-28

    Glycopyrrolate Tablets Recalled for Failed Impurities and Degradation Specifications

    Glycopyrrolate tablets distributed nationwide are being recalled due to failed impurities and degradation specifications. Patients with affected lots should discontinue use and consult their healthcare provider.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0061-2023·2022-11-23

    Phenoxybenzamine Hydrochloride Capsules Recalled for Failed Specifications

    Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.

    Product
    Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2023·2022-10-26

    FDA Recalls Flunisolide Nasal Solution Due to Out-of-Specification Impurities

    Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution nationwide because the product contains impurities that exceed acceptable limits. The recall affects two lots distributed across the United States.

    Product
    FLUNISOLIDE — FLUNISOLIDE (FLUNISOLIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1310-2022·2022-08-17

    Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation

    Hikma Pharmaceuticals is recalling 82,700 vials of Lorazepam Injection due to failed quality specifications for impurities and degradation. Lot #070096 (expired July 2023) was distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1307-2022·2022-08-17

    Lorazepam injection vials recalled nationwide for manufacturing specification failures

    Hikma Pharmaceuticals is recalling approximately 4.7 million vials of Lorazepam injection nationwide after finding out-of-specification related compounds during quality testing. The affected lots expire between June and August 2023.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide