The Recall Desk

Hazard

Sterility Assurance recalls

309 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 sterility assurance 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.

201–225 of 309

  • SevereFDA (Drugs)·D-0658-2022·2022-03-23

    Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0657-2022·2022-03-23

    Hydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.

    Product
    Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0463-2022·2022-02-09

    Medroxyprogesterone Acetate Injection Recalled for Sterility Assurance

    Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.

    Product
    Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0419-2022·2022-02-02

    Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall

    Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.

    Product
    Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0422-2022·2022-02-02

    Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0395-2022·2022-02-02

    Lidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.

    Product
    Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0416-2022·2022-02-02

    Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall

    Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.

    Product
    Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0401-2022·2022-02-02

    Edge Pharma Edetate Disodium Ophthalmic Solution Recall for Sterility Concerns

    Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.

    Product
    Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0418-2022·2022-02-02

    Phenylephrine Injection Recall Due to Sterility Assurance Concerns

    Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.

    Product
    PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0426-2022·2022-02-02

    Vancomycin HCl Injection Recalled for Sterility Assurance Issues

    Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2022·2022-02-02

    Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk

    Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.

    Product
    Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0411-2022·2022-02-02

    Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.

    Product
    Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2022·2022-02-02

    Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance

    Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0421-2022·2022-02-02

    Sterile Ophthalmic Solution Lacks Assurance of Sterility

    Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0415-2022·2022-02-02

    Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.

    Product
    Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0423-2022·2022-02-02

    Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance

    Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution distributed nationwide.

    Product
    Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0397-2022·2022-02-02

    Ceftazidime Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling Ceftazidime sterile ophthalmic solution for intraocular injection due to lack of assurance of sterility. The recall affects 168 syringes distributed nationwide.

    Product
    Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0420-2022·2022-02-02

    Edge Pharma Phenylephrine/Tropicamide Ophthalmic Solution Sterility Recall

    Edge Pharma is recalling a sterile ophthalmic solution (Phenylephrine HCl/Tropicamide 2.5%/1%) because the manufacturer cannot assure sterility of the product. The recall affects 363 droptainers distributed nationwide.

    Product
    Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0405-2022·2022-02-02

    Methacholine Challenge Test Kit Recalled for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Methacholine Challenge 5-Syringe Test Kits nationwide due to lack of assurance of sterility. The sterile inhalation solution may not meet sterility standards.

    Product
    Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg),
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0400-2022·2022-02-02

    Edge Pharma EDTA Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma, LLC is recalling Edetate Disodium (EDTA) 1.5% Sterile Ophthalmic Solution nationwide due to lack of assurance of sterility. The recalled product is a single-dose eye drop solution.

    Product
    Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0409-2022·2022-02-02

    Mitomycin-C Ophthalmic Solution Recall Due to Sterility Assurance

    Edge Pharma is recalling Mitomycin-C sterile ophthalmic solution syringes because the manufacturer lacks assurance of sterility. The recall affects 154 syringes distributed nationwide.

    Product
    Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0371-2022·2022-01-19

    Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals is recalling Norepinephrine Bitartrate Injection USP due to lack of assurance of sterility. The affected lot is distributed in Tennessee, Mississippi, and Ohio.

    Product
    Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0317-2022·2022-01-05

    SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance

    SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2022·2022-01-05

    SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 bags distributed across the United States.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled Due to Sterility Assurance Concerns

    SterRx is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The product is used in hospital and clinical settings to treat low blood pressure.

    Product
    NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
    Category
    Drug
    Distribution
    Distributed nationwide