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.

376–400 of 2383

  • SevereFDA (Drugs)·D-0069-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.

    Product
    LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0106-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.

    Product
    Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Bl
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0057-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,871 vials of Human Chorionic Gonadotropin 20,000 Units due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0029-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0013-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Hydroxocobalamin Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 15 syringes of C-Hydroxocobalamin 25 mg/mL injection solution because the product's sterility cannot be guaranteed.

    Product
    C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0009-2020·2019-10-09

    Colonia Care Pharmacy Recalls Dexamethasone Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 37 vials of C-Dexamethasone 24mg/mL injection solution because the sterility of the product cannot be guaranteed.

    Product
    C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0031-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Phenol Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5% vials because the sterility of the product cannot be guaranteed.

    Product
    C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0072-2020·2019-10-09

    KRS Global Biotechnology Recalls Lyophilized Injection Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 497 vials of a lyophilized injection product because the company cannot ensure the product is sterile.

    Product
    Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0021-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Papav/Phentol/PGE1 vials because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0096-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.

    Product
    Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0114-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.

    Product
    Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0027-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0086-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.

    Product
    PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0082-2020·2019-10-09

    KRS Global Biotechnology Recalls Norepinephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.

    Product
    Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0071-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine/Bupivacaine/Hyaluronidase ophthalmic injections due to a lack of assurance of sterility.

    Product
    LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0098-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin Acetate 3 mg vials because the company cannot ensure the product is sterile.

    Product
    Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0093-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling 258 vials of Sermorelin Acetate and GHRP-2 because the product lacks assurance of sterility.

    Product
    Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0084-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection

    KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0046-2020·2019-10-09

    KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 3,895 syringes of ephedrine sulfate due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0062-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.

    Product
    Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0015-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Interferon Alfa2B Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Interferon Alfa2B ophthalmic solution because the product's sterility cannot be guaranteed.

    Product
    C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0003-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Acetylcysteine Ophthalmic 10% Solution because the sterility of the product cannot be guaranteed.

    Product
    C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0063-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.

    Product
    Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2020·2019-10-09

    KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
    Category
    Drug
    Distribution
    Distributed nationwide