The Recall Desk

Hazard

Non Sterility recalls

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

What the numbers show

Total
145
Critical
85
Severe
55
Most recent
2026-07-01

Of the 145 non sterility recalls we have scored against our rubric, 85 (59%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 55 (38%) 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 non sterility 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 145

  • SevereFDA (Drugs)·D-0300-2024·2024-02-14

    Target Lubricant Eye Drops Recalled for Non-Sterility

    Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 bottles.

    Product
    Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2024·2024-02-14

    FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility

    Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. Consumers should discontinue use immediately.

    Product
    Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2024·2024-02-14

    FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility

    The FDA has issued a Class I recall of Dry Eye Relief eye drops sold nationwide due to non-sterility concerns. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary recall affecting 12,960 bottles.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2024·2024-02-14

    Lubricant Eye Drops Recalled Due to Non-Sterility Concerns

    Rite Aid is recalling 7,296 bottles of lubricant eye drops nationwide due to non-sterility. The FDA has classified this as a Class I recall.

    Product
    Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2024·2024-02-14

    Eye Irritation Relief Drops Recalled Nationwide for Non-Sterility

    Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2024·2024-02-14

    CVS Health Lubricating Gel Drops Recalled Due to Non-Sterility

    CVS Health brand Lubricating Gel Drops are being recalled due to non-sterility concerns. The voluntary recall affects approximately 110,832 bottles distributed nationwide.

    Product
    CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0296-2024·2024-02-14

    CVS Multi Action Relief Drops Recalled for Non-Sterility

    CVS brand Multi Action Relief Drops are being recalled nationwide due to non-sterility, which could allow microbial contamination in the product. The voluntary recall covers all lots of the eye drops.

    Product
    CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0131-2024·2023-11-29

    Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility

    Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0107-2024·2023-11-29

    Polyvinyl Alcohol Eye Drops Recalled for Non-Sterile Manufacturing Conditions

    FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.

    Product
    Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2024·2023-11-29

    LEADER Lubricant Eye Drops Recalled Nationwide for Non-Sterility Concerns

    LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2024·2023-11-29

    Eye drops recalled for non-sterility due to bacterial contamination

    Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0136-2024·2023-11-29

    LEADER Lubricant Eye Drops Recalled for Non-Sterility and Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.

    Product
    LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0134-2024·2023-11-29

    FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0037-2024·2023-10-11

    FDA Recalls Dr. Berne's MSM Drops Due to Non-Sterility Concerns

    Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.

    Product
    Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0919-2023·2023-07-19

    EzriCare Artificial Tears Eye Drops Recalled for Bacterial Contamination

    EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.

    Product
    Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2023·2023-03-15

    Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination

    Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.

    Product
    Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0648-2022·2022-02-23

    HCG 6,000iu Injection Recalled for Bacterial Contamination

    Revive Rx is recalling HCG 6,000iu injectable medication due to bacterial contamination (Paenibacillus lautus) identified in the product. The affected lot was distributed nationwide.

    Product
    HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2022·2022-02-23

    Paragard T380A Intrauterine Contraceptive Device Recall for Non-Sterility

    CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.

    Product
    PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0786-2021·2021-09-08

    Akorn Artificial Tears Ointment Recalled for Non-Sterility

    Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.

    Product
    Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0767-2021·2021-09-01

    SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0708-2021·2021-08-18

    Injectable Drug Syringes Recalled for Non-Sterility

    Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0716-2021·2021-08-18

    Injectable Drug Recalled for Non-Sterility Risk

    Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0713-2021·2021-08-18

    Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.

    Product
    MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0717-2021·2021-08-18

    Hydromorphone HCL-Bupivacaine HCL Injectable Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5M
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0718-2021·2021-08-18

    Compounded Progesterone Oil Recalled for Non-Sterility Risk

    People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.

    Product
    C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
    Category
    Drug
    Distribution
    2 states