The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (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.

1–25 of 2383

  • 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 — CLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE)
    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
  • 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
  • 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 10
    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-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-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-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-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
  • 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 70004025164
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0376-2024·2024-03-20

    TRP Blur Relief Eye Drops Recalled Nationwide for Sterility Assurance Failure

    TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.

    Product
    TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0374-2024·2024-03-20

    FDA Recalls Betimol Eye Drops for Sterility and Container Closure Defects

    Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.

    Product
    BETIMOL — BETIMOL (TIMOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0028-2024·2023-10-11

    HYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 1,190 units of HYDROmorphone injectable syringes nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.

    Product
    HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0027-2024·2023-10-11

    FDA recalls HYDROmorphone injectable syringes for sterility assurance defect

    The FDA is recalling HYDROmorphone injectable syringes from Central Admixture Pharmacy Services Inc. due to lack of sterility assurance. Approximately 1,190 syringes nationwide are affected.

    Product
    HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0019-2024·2023-10-11

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue

    Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0011-2024·2023-10-11

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.

    Product
    fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1152-2023·2023-09-27

    TRP Natural Eyes Sterile Eye Drops Recalled Due to Sterility Assurance

    TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1114-2023·2023-09-06

    Neonatal TPN Starter Bag recalled for sterility assurance concerns

    Central Admixture Pharmacy Services is recalling a neonatal TPN bag due to lack of validated sanitation cycles, affecting 84 units distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1125-2023·2023-09-06

    FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.

    Product
    PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1028-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 196 bags of cardioplegia solution nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1040-2023·2023-08-09

    Cardioplegia Solution IV Bags Recalled Due to Sterility Assurance

    Central Admixture Pharmacy Services is recalling 72 bags of Cardioplegia Solution due to insufficient validation data for product sterilization processes.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
    Category
    Drug
    Distribution
    Distributed nationwide