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.

51–75 of 191

  • ModerateFDA (Drugs)·D-0982-2022·2022-06-15

    Ophthalmic Drug Xiidra Recalled for Failed Impurity Specifications

    Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.

    Product
    XIIDRA — XIIDRA (LIFITEGRAST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0748-2022·2022-04-13

    Prescription Eye Drop Medication Recalled for Subpotency and Contamination

    Mylan Pharmaceuticals recalls one lot of Travoprost ophthalmic solution due to subpotency and impurity issues found during stability testing. Patients should consult their pharmacist or physician if they have medication from this lot.

    Product
    TRAVOPROST OPHTHALMIC SOLUTION, 0.004% — TRAVOPROST OPHTHALMIC SOLUTION, 0.004% (TRAVOPROST OPHTHALMIC SOLUTION, 0.004%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0726-2022·2022-04-06

    Prescription Atorvastatin Calcium Tablets Recalled for Failed Quality Specifications

    Dr. Reddy's Laboratories is recalling 28,068 bottles of Atorvastatin Calcium 80 mg tablets nationwide due to failed impurity and degradation specifications. No illnesses or injuries have been reported.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0637-2022·2022-03-09

    Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

    Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.

    Product
    Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0289-2022·2021-12-29

    Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications

    The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.

    Product
    Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0263-2022·2021-12-01

    Carvedilol Tablets Recalled for Failed Impurities and Degradation Specifications

    Aurobindo Pharma USA Inc. is recalling Carvedilol 6.25 mg tablets nationwide due to failed impurities and degradation specifications. Affected containers bear Batch QG0619030-A with expiration date 11/2022.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2022·2021-11-24

    Clonidine Transdermal System patches recalled for impurities and degradation

    Teva Pharmaceuticals USA is recalling 64,978 Clonidine Transdermal System patches (0.1 mg/day) due to failed specifications for impurities and degradation. The recall affects nationwide and Puerto Rico distribution.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2021·2021-09-29

    Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications

    American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0689-2021·2021-07-28

    Erythromycin Topical Solution 2% Recalled for Failed Impurities Specifications

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL, Lot 14180) distributed nationwide because it failed impurities and degradation specifications.

    Product
    Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0639-2021·2021-06-30

    Phytonadione 5 mg Tablets Recalled for Failed Impurity Specifications

    Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.

    Product
    Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0599-2021·2021-06-02

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets due to the presence of degradation impurities.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2021·2021-05-26

    KVK-Tech Recalls Hydrocodone and Homatropine Tablets for Impurity Failures

    KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0320-2021·2021-04-14

    Sun Pharmaceutical Recalls Ganirelix Acetate Injection Due to Impurities

    Sun Pharmaceutical Industries is recalling 91,211 syringes of Ganirelix Acetate Injection because the product failed impurities and degradation specifications.

    Product
    Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0312-2021·2021-03-31

    Golden State Medical Supply Recalls Omeprazole Capsules Due to Impurities

    Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules because stability testing revealed unknown impurities.

    Product
    Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0308-2021·2021-03-24

    Breckenridge Recalls Omeprazole Capsules Due to Unknown Impurities

    Breckenridge Pharmaceutical is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, 20 mg, due to out-of-specification results for unknown impurities.

    Product
    Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0291-2021·2021-03-10

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they contain impurities that exceed FDA specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0115-2021·2020-12-09

    InvaTech Recalls Levocetirizine Dihydrochloride Tablets Due to Stability Failure

    InvaTech Pharma Solutions is recalling specific lots of Levocetirizine Dihydrochloride Tablets 5 mg because one lot failed stability testing.

    Product
    Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0015-2021·2020-10-14

    Pharmaceutical Associates Recalls Citalopram Oral Solution Due to Impurities

    Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.

    Product
    Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1314-2020·2020-06-24

    Aurobindo Pharma Recalls Olanzapine Tablets Due to Impurity Failures

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.

    Product
    Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1284-2020·2020-06-10

    Triova Recalls Estriol USP Micronized 5 G Due to Impurities

    Triova Pharmaceuticals is recalling Estriol USP Micronized 5 G because the product failed specifications for organic impurities.

    Product
    Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1063-2020·2020-03-04

    Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures

    Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.

    Product
    Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hun
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2020·2020-01-22

    Sun Pharmaceutical Recalls Sumatriptan Succinate Tablets Due to Impurities

    Sun Pharmaceutical Industries is recalling specific lots of Sumatriptan Succinate 50 mg tablets because they failed impurity specifications.

    Product
    SUMATRIPTAN SUCCINATE — SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0622-2020·2019-12-25

    Medisca Recalls Estriol USP Micronized Due to Failed Impurity Specifications

    Medisca, Inc. is recalling specific lots of Estriol, USP (Micronized) because the product failed impurities and degradation specifications.

    Product
    Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
    Category
    Drug
    Distribution
    Distributed nationwide