The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,048 (74%) 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 lack of 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.

551–575 of 1417

  • SevereFDA (Drugs)·D-0354-2020·2019-11-27

    Altaire Recalls Neo-Polycin HC Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Neo-Polycin HC ophthalmic ointment because the company cannot guarantee the product is sterile.

    Product
    Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2020·2019-11-27

    Altaire Recalls Polycin Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Polycin Ophthalmic Ointment because the company cannot ensure the product is sterile.

    Product
    Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2020·2019-11-27

    Altaire Recalls OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic

    Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% sterile anesthetic single-dose vials due to a lack of assurance of sterility.

    Product
    OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2020·2019-11-27

    Altaire Sterile Eye Wash Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash because the company cannot guarantee the product is sterile.

    Product
    Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0489-2020·2019-11-27

    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 and return it to the point of purchase.

    Product
    Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2020·2019-11-27

    CVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Dry Eye Relief 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 Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2020·2019-11-27

    Altaire Recalls OCuSOFT Eye Wash Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Eye Wash Sterile Isotonic because the product may not be sterile. Consumers should stop using the product and contact the manufacturer.

    Product
    OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2020·2019-11-27

    Altaire Recalls Natural Ophthalmics Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Natural Ophthalmics Allergy Desensitization Eye Drops because the company cannot ensure the product is sterile.

    Product
    Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0358-2020·2019-11-27

    Altaire Recalls Puralube Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Puralube Ointment Petrolatum Ophthalmic Ointment because the product may not be sterile.

    Product
    Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2020·2019-11-27

    CVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Dry Eye Relief Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 101,712 units distributed nationwide.

    Product
    CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0363-2020·2019-11-27

    Altaire Recalls Walgreen's Lubricant Eye Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Walgreen's Lubricant Eye Ointment because the product lacks assurance of sterility. The recall covers 45,672 units distributed nationwide.

    Product
    Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0389-2020·2019-11-27

    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 (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0386-2020·2019-11-27

    CVS Lubricant Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Extra Strength Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0383-2020·2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    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, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0418-2020·2019-11-27

    Altaire Recalls ActivEyes Sterile Altalube Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling ActivEyes Sterile Altalube Ointment because the company cannot guarantee the product is sterile. Consumers should stop using the product and return it to the pharmacy.

    Product
    ALTALUBE — ALTALUBE (MINERAL OIL AND PETROLATUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0373-2020·2019-11-27

    CVS Health Natural Tears Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Natural Tears Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 152,369 units distributed nationwide.

    Product
    CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2020·2019-11-20

    Viatrexx-ANS/CNS Recalled for Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-ANS/CNS vials because they were manufactured in a manner that cannot guarantee sterility.

    Product
    Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2020·2019-11-20

    Viatrexx-Hair Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Hair sterile multi-dose vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2020·2019-11-20

    Viatrexx-Infla Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Infla vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.

    Product
    Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0327-2020·2019-11-20

    Viatrexx-MuSkel-Neural Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-MuSkel-Neural vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0329-2020·2019-11-20

    Viatrexx-Ithurts Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Ithurts sterile multi-dose vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0341-2020·2019-11-20

    Viatrexx-Immunexx Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling 18 vials of Viatrexx-Immunexx because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC/B12/Carnitine Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC/B12(C)/Carnitine injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s0709
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0289-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Test Cyp/Prop/Deca-Nan Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Test Cyp/Prop/Deca-Nan 250mg/ml vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide