The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 sterility failure 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.

576–600 of 1691

  • SevereFDA (Drugs)·D-0764-2020·2020-01-22

    Assurance Infusion Recalls Quadmix Injection Vials Due to Sterility Concerns

    Assurance Infusion is recalling 190 vials of Quadmix injection nationwide due to a lack of sterility assurance. The recall covers nine specific lots distributed across the United States.

    Product
    QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0738-2020·2020-01-22

    Assurance Infusion Recalls Hydrom and Prialt Injection Due to Sterility Concerns

    Assurance Infusion is recalling Hydrom and Prialt injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0745-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Injection Due to Sterility Concerns

    Assurance Infusion is recalling Hydromorphone 4mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0741-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Injection Due to Sterility Concerns

    Assurance Infusion is recalling Hydromorphone 1mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2020·2020-01-22

    Assurance Infusion Recalls QUADMIX FORTE Vials Due to Sterility Concerns

    Assurance Infusion is recalling QUADMIX FORTE in 1 mL vials because of a lack of sterility assurance. The recall covers 5 vials distributed nationwide.

    Product
    QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0758-2020·2020-01-22

    Recall of Assurance Infusion Morphine Injection for Sterility Concerns

    Assurance Infusion is recalling Morphine 4mg/mL Injection in 20mL syringes due to lack of sterility assurance. The recall affects specific lots distributed nationwide.

    Product
    MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0523-2020·2019-12-04

    New Vitalis Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

    New Vitalis Pharmacy is recalling Testosterone Cypionate and Propionate oil injection solutions due to a lack of sterility assurance.

    Product
    Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2020·2019-11-27

    Altaire Recalls Grandall Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Grandall Colirio Ojo De Aguila Eye Drops because the company cannot guarantee the product is sterile.

    Product
    Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2020·2019-11-27

    Altaire Eye Ointment Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling iSolutions ActivEyes Nighttime Lubricant Eye Ointment due to a lack of assurance of sterility.

    Product
    iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0443-2020·2019-11-27

    Altaire Recalls OCuSOFT Tetravisc Forte Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Forte ophthalmic anesthetic because the product lacks assurance of sterility.

    Product
    OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0487-2020·2019-11-27

    Clear Eyes Redness Relief Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Clear Eyes Redness Relief eye drops due to a lack of assurance of sterility. Consumers should stop using the product.

    Product
    Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0479-2020·2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the agency could not ensure the product was sterile.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0427-2020·2019-11-27

    Altaire NanoTears Lubricant Gel Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling 137 units of iSolutions NanoTears HA Preservative Free Multi-Dose Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0435-2020·2019-11-27

    Altaire Pharmaceuticals Recalls iSolutions Nano Tears XP Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears XP eye drops because the company cannot guarantee the product is sterile.

    Product
    iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2020·2019-11-27

    Altaire Recalls Ocusoft Tears Again Lubricant Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Ocusoft Tears Again Lubricant Eye Drops because the company cannot guarantee the product is sterile.

    Product
    Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0367-2020·2019-11-27

    Altaire Recalls Equate Eye Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Restore PM Nighttime Lubricant Eye Ointment because the product may not be sterile.

    Product
    Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0422-2020·2019-11-27

    Altaire Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE — FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE (FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2020·2019-11-27

    Altaire Recalls OCuSOFT Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Sterile Lubricant Eye Drops because the company cannot guarantee the product's sterility.

    Product
    OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0426-2020·2019-11-27

    Altaire Goniotaire Ophthalmic Solution Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling Goniotaire ophthalmic solution due to a lack of assurance of sterility. The recall affects 202,266 units distributed nationwide.

    Product
    GONIOTAIRE — GONIOTAIRE (HYPROMELLOSE 2906 (4000 MPA.S))
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0390-2020·2019-11-27

    CVS Lubricant Eye Drops Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2020·2019-11-27

    Altaire Recalls Equate Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricating Eye Drops because the company cannot guarantee the product is sterile.

    Product
    Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the point of purchase.

    Product
    CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide