The Recall Desk

Hazard

Lack Of Sterility recalls

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

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.

51–75 of 447

  • HighFDA (Drugs)·D-0475-2025·2025-07-02

    CJC-1295 Injectable Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling 60 syringes of CJC-1295 Injectable due to lack of assurance of sterility. Non-sterile injectables pose a risk of infection to patients.

    Product
    CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0483-2025·2025-07-02

    Tirzepatide Injections Recalled Due to Sterility Assurance Issues

    Thrive Health Solutions is recalling 826 syringes of Tirzepatide Injections nationwide due to lack of assurance of sterility.

    Product
    Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0479-2025·2025-07-02

    Semaglutide Pre-filled Syringes Recalled for Sterility Assurance Issues

    Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes nationwide for lack of assurance of sterility. Patients with affected syringes should contact their healthcare provider.

    Product
    Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0373-2025·2025-04-30

    Ketamine Syringes Recalled for Leaking and Sterility Assurance Failures

    Leiters Health is recalling 49,830 ketamine HCl syringes nationwide due to leaking and damaged units that compromise sterility assurance. Affected patients should contact their healthcare provider.

    Product
    Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1527-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for lack of sterility assurance

    Avanos Medical is recalling 1,040 Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. These devices are used for airway suctioning in adults.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1526-2025·2025-04-23

    Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (model 2271418-5) with lot code 1555430 due to lack of sterility assurance. 1,420 units were distributed worldwide.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0354-2025·2025-04-16

    Methocarbamol injection recalled for lack of sterility assurance

    Somerset Therapeutics is recalling methocarbamol injection nationwide due to bacterial contamination detected in manufacturing sterility testing. No illnesses have been reported.

    Product
    METHOCARBAMOL — METHOCARBAMOL (METHOCARBAMOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0303-2025·2025-04-02

    Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue

    Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2025·2024-12-25

    OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

    REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    REGENER-EYES — REGENER-EYES (REGENER-EYES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2025·2024-12-25

    Ophthalmic solution recalled for lack of sterility assurance

    Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.

    Product
    REGENER-EYES — REGENER-EYES (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0663-2024·2024-10-02

    Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance

    Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.

    Product
    Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2024·2024-09-11

    Compounded Semaglutide Recalled Due to Lack of Sterility Assurance

    ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.

    Product
    SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0651-2024·2024-09-11

    Compounded Tirzepatide Injectable Vials Recalled for Sterility Assurance Issues

    ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were distributed nationwide.

    Product
    Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0514-2024·2024-06-05

    Intraocular injection drug recalled due to sterility assurance failure

    Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac intraocular injections (38,060 vials) due to lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0516-2024·2024-06-05

    Moxifloxacin Intraocular Injection Recalled for Sterility Assurance

    Imprimis NJOF, LLC is recalling specific lots of Moxifloxacin intraocular injections nationwide due to lack of assurance of sterility.

    Product
    Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2024·2024-06-05

    FDA Recalls Epinephrine-Lidocaine Intraocular Injections Due to Sterility Concerns

    Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial 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-0432-2024·2024-04-10

    Fentanyl Citrate Injectable Recalled for Lack of Sterility Assurance

    IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.

    Product
    fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0410-2024·2024-04-03

    Hydromorphone Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0399-2024·2024-04-03

    FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.

    Product
    fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0409-2024·2024-04-03

    FDA recalls HYDROmorphone injection for lack of sterility assurance

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.

    Product
    HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2024·2024-04-03

    HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues

    SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0418-2024·2024-04-03

    Phenylephrine HCl Injectable Recalled Nationwide for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.

    Product
    PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0413-2024·2024-04-03

    Neostigmine methylsulfate injection recalled nationwide due to sterility concerns

    SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).

    Product
    neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0425-2024·2024-04-03

    Vancomycin Injectable Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.

    Product
    VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0383-2024·2024-03-20

    TRP Natural Eyes Red Eye Relief eye drops recalled for sterility concerns

    The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.

    Product
    TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
    Category
    Drug
    Distribution
    Distributed nationwide