The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 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 1,055 (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.

526–550 of 1423

  • SevereFDA (Drugs)·D-0700-2020·2020-01-22

    Assurance Infusion Recalls BUP 30MG/HYDROM 10MG/ML Injection Due to Sterility Concerns

    Assurance Infusion is recalling BUP 30MG/HYDROM 10MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.

    Product
    BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0732-2020·2020-01-22

    Assurance Infusion Recalls Fentanyl Injection Due to Sterility Concerns

    Assurance Infusion is recalling Fentanyl 5mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0773-2020·2020-01-22

    Assurance Infusion Recalls TRIMIX Injection Vials Due to Sterility Concerns

    Assurance Infusion is recalling 1,290 vials of TRIMIX injection nationwide due to a lack of sterility assurance. No specific illnesses or injuries are reported in the source text.

    Product
    TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0610-2020·2019-12-18

    Surgery Pharmacy Services Recalls 1,149 Bags of Memorial Central TPN

    Surgery Pharmacy Services is recalling 1,149 bags of Memorial Central TPN due to a lack of sterility assurance. The product was distributed in Georgia and Tennessee.

    Product
    Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0611-2020·2019-12-18

    Surgery Pharmacy Services Recalls Trisodium Citrate CRRT Solution for Sterility Concerns

    Surgery Pharmacy Services is recalling 84 bags of Trisodium Citrate 0.5% CRRT Solution due to a lack of sterility assurance. The product was distributed in Georgia and Tennessee.

    Product
    Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0486-2020·2019-11-27

    Altaire Recalls Grandall Oftal-Mycin Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Grandall Oftal-Mycin Ophthalmic Ointment because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

    Product
    Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2020·2019-11-27

    Altaire Pharmaceuticals Recalls iSolutions Nano Tears Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops because the product may not be sterile.

    Product
    iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2020·2019-11-27

    Altaire Recalls OCuSOFT Homatropine Hydrobromide Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, due to a lack of assurance of sterility. The recall covers 81,403 units distributed nationwide.

    Product
    OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
    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-0353-2020·2019-11-27

    Altaire Recalls Neo-Polycin Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Neo-Polycin ophthalmic ointment due to a lack of assurance of sterility. The recall covers 121,572 containers distributed nationwide.

    Product
    Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0380-2020·2019-11-27

    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 covers 39,288 units distributed nationwide.

    Product
    CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA 02895
    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-0365-2020·2019-11-27

    Altaire Recalls Equate Sterile Lubricant Stye Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Sterile Lubricant Stye Ointment because the company cannot ensure the product is sterile.

    Product
    Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50
    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-0474-2020·2019-11-27

    Puralube Ophthalmic Ointment Recalled Due to Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Puralube Ophthalmic Ointment because the product lacks assurance of sterility.

    Product
    Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0411-2020·2019-11-27

    CVS Health Redness Relief Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health 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
    CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, 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-0447-2020·2019-11-27

    OCuSOFT Eye Wash Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling OCuSOFT Eye Wash due to a lack of assurance of sterility. Consumers should stop using the product and contact the manufacturer.

    Product
    OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01
    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
  • 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-0419-2020·2019-11-27

    Altaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Ciprofloxacin HCL Ophthalmic Solution due to a lack of assurance of sterility. The recall affects 3,060 units distributed nationwide.

    Product
    CIPROFLOXACIN HCL OPHTHALMIC — CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
    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-0403-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns

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

    Product
    CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0475-2020·2019-11-27

    Altaire Recalls Equate Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricant Gel Drops because the product lacks assurance of sterility.

    Product
    Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52
    Category
    Drug
    Distribution
    Distributed nationwide