The Recall Desk

Hazard

Sterility recalls

2,419 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,419
Critical
2
Severe
2,147
Most recent
2026-10-14

Of the 2,419 sterility recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,147 (89%) 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 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 2419

  • SevereFDA (Drugs)·D-0862-2026·2026-09-30

    Sterling Recalls Carboxymethylcellulose Sodium Eye Drops Due to Sterility Concerns

    Sterling Pharmaceutical Services LLC is recalling specific lots of Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant due to a lack of assurance of sterility.

    Product
    Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0858-2026·2026-09-30

    Walgreens Lubricant Eye Drops Recalled for Sterility Assurance Concerns

    Sterling Pharmaceutical Services LLC is recalling Walgreens Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 199,600 packs distributed nationwide.

    Product
    WALGREENS LUBRICANT EYE DROPS — WALGREENS LUBRICANT EYE DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0856-2026·2026-09-30

    Sodium Chloride Ophthalmic Solution Recalled for Sterility Assurance Issues

    Sterling Pharmaceutical Services is recalling Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, due to a lack of assurance of sterility.

    Product
    SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% — SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% (SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0859-2026·2026-09-30

    Sterling Pharmaceutical Recalls Lubricating Tears Due to Sterility Concerns

    Sterling Pharmaceutical Services LLC is recalling specific lots of Lubricating Tears because the company cannot guarantee the product is sterile.

    Product
    LUBRICATING TEARS — LUBRICATING TEARS (CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0861-2026·2026-09-30

    Sterling Recalls Major LubriFresh P.M. Ointment for Sterility Concerns

    Sterling Pharmaceutical Services LLC is recalling Major LubriFresh P.M. Nighttime Ointment due to a lack of assurance of sterility. The recall covers 34,368 tubes distributed nationwide.

    Product
    Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3151-2026·2026-09-23

    AVID Medical Recalls Haylard 18G Single Shot Epi Trays Due to Sterility Concerns

    AVID Medical is recalling 1,640 Haylard 18G Single Shot Epi Trays because they contain Sodium Chloride ampules subject to a separate recall for potential quality and sterility issues.

    Product
    Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-3153-2026·2026-09-23

    AVID Medical Recalls Haylard Basic Biopsy Trays Due to Sterility Concerns

    AVID Medical is recalling Haylard Basic Biopsy Trays because they contain Sodium Chloride ampules subject to a separate recall for quality and sterility issues.

    Product
    Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0853-2026·2026-09-23

    Pfizer Recalls Dopamine Hydrochloride Injection Due to Sterility Concerns

    Pfizer is recalling specific lots of Dopamine Hydrochloride Injection due to a lack of assurance of sterility. The affected product is distributed nationwide.

    Product
    DOPAMINE HYDROCHLORIDE — DOPAMINE HYDROCHLORIDE (DOPAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3154-2026·2026-09-23

    AVID Medical Recalls Biopsy Kits Due to Sterility Concerns

    AVID Medical is recalling 340 biopsy kits because they contain sodium chloride ampules subject to a separate recall for quality and sterility issues.

    Product
    Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0865-2026·2026-09-16

    American Regent Recalls Epinephrine Vials Due to Particulate Matter

    American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection due to the presence of particulate matter and broken vials.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0819-2026·2026-09-09

    Baxter Recalls Vasopressin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Vasopressin in 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE — VASOPRESSIN IN 0.9% SODIUM CHLORIDE (VASOPRESSIN IN 0.9% SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0766-2026·2026-08-19

    Prestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns

    Prestige Brands Holdings is recalling Clear Eyes Maximum Itchy Eye Relief eye drops due to a lack of assurance of sterility and potential contamination.

    Product
    CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0715-2026·2026-07-29

    ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops due to a lack of assurance of sterility. The recall affects multiple lots distributed nationwide within the United States.

    Product
    Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0718-2026·2026-07-29

    FDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns

    The FDA is recalling ROHTO OPTIC GLOW sterile eye drops due to a lack of assurance of sterility. The recall affects 1,278,457 cartons distributed nationwide in the U.S.

    Product
    Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0717-2026·2026-07-29

    ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

    Rohto-Mentholatum is recalling ROHTO Cooling Eye Drops due to lack of assurance of sterility. The recall affects 499,673 cartons distributed nationwide in the U.S.

    Product
    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0350-2026·2026-03-04

    Fluorescein Sodium Ophthalmic Strips Recalled Over Sterility Concerns

    Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.

    Product
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS — C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2026·2026-03-04

    Vista Hypromelose Dry Eye Relief Eye Drops Recalled Due to Sterility Concerns

    Vizcure Pharmaa Private Limited is recalling Vista Hypromelose Dry Eye Relief eye drops due to lack of assurance of sterility. The products were not manufactured in conformance with current good manufacturing practices.

    Product
    VISTA HYPROMELLOSE DRY EYE RELIEF — VISTA HYPROMELLOSE DRY EYE RELIEF (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0296-2025·2025-04-02

    Compounded Fentanyl-Bupivacaine Epidural Injections Recalled for Sterility Failure

    QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0164-2025·2025-01-01

    Diagnostic drug kit recalled due to sterility concerns and vial integrity issues

    Curium US is recalling Technetium TC 99m Sestamibi diagnostic kits (Lot 092-24006) due to improper vial crimps that could compromise sterility assurance. The recall affects approximately 5,160 vials distributed nationwide.

    Product
    TECHNETIUM TC 99M SESTAMIBI — TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0652-2024·2024-09-11

    Compounded Semaglutide Injection Vials Recalled for Sterility Concerns

    ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.

    Product
    SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0654-2024·2024-09-11

    ProRx Compounded Semaglutide/Cyanocobalamin Injection Recalled Due to Sterility Assurance Issues

    ProRx LLC is recalling 500 vials of compounded Semaglutide/Cyanocobalamin Injection (Lot #ProRx031924-1) distributed nationwide in the United States due to lack of sterility assurance. The beyond-use date is 09/18/2024.

    Product
    Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0512-2024·2024-06-05

    Epinephrine-Lidocaine Intraocular Injection Vials Recalled for Sterility Assurance

    Imprimis NJOF, LLC is recalling 14,180 vials of Epinephrine-Lidocaine intraocular injection due to lack of assurance of sterility. These vials were distributed nationwide within the United States.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0401-2024·2024-04-03

    FDA Recalls Fentanyl-Bupivacaine Injection Due to Sterility Assurance Concerns

    SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to lack of assurance of sterility.

    Product
    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0405-2024·2024-04-03

    HYDROmorphone Injection Syringes Recalled for Sterility Assurance Issue

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injection syringes due to lack of assurance of sterility. The recall affects 5,734 syringes distributed nationwide.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
    Category
    Drug
    Distribution
    Distributed nationwide