The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) 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 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.

626–650 of 1423

  • SevereFDA (Drugs)·D-0094-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Injections Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin Acetate injections because the company cannot ensure the product is sterile. The recall covers 218 cartridges distributed nationwide.

    Product
    Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0040-2020·2019-10-09

    KRS Global Biotechnology Recalls Ascorbic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,219 vials of Ascorbic Acid (Tapioca Source) 25 g/50 mL due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0109-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee 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), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0083-2020·2019-10-09

    KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee the product is sterile.

    Product
    OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0010-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-EDETATE DISODIUM 1.5% Ophthalmic Solution

    Colonia Care Pharmacy is recalling specific lots of C-EDETATE DISODIUM 1.5% Ophthalmic Solution because the sterility of the product cannot be guaranteed.

    Product
    C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0048-2020·2019-10-09

    KRS Global Biotechnology Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.

    Product
    ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0061-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.

    Product
    Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0101-2020·2019-10-09

    Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.

    Product
    Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0092-2020·2019-10-09

    KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns

    KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.

    Product
    Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1852-2019·2019-09-18

    Pfizer Recalls Bacteriostatic Water Vials Due to Sterility Concerns

    Pfizer is recalling 185,700 vials of Bacteriostatic Water for Injection due to a lack of assurance of sterility. The product was distributed nationwide in the US and Puerto Rico.

    Product
    BACTERIOSTATIC WATER — BACTERIOSTATIC WATER (BACTERIOSTATIC WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1748-2019·2019-08-21

    Infusion Options Recalls ALIMTA Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling ALIMTA 785 mg and 1000 mg intravenous infusion bags in New York due to a lack of assurance of sterility.

    Product
    ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1780-2019·2019-08-21

    GAZYVA Infusion Recall Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling GAZYVA 100 mg and 900 mg infusion products in New York due to a lack of assurance of sterility.

    Product
    GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1744-2019·2019-08-21

    Infusion Options Recalls Oxytocin IV Solution Due to Sterility Concerns

    Infusion Options, Inc. is recalling Oxytocin 60 units/1000 mL Lactated Ringers IV Solution because the product lacks assurance of sterility. The recall affects 820 bags distributed in New York.

    Product
    Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1768-2019·2019-08-21

    Infusion Options Recalls Diphenhydramine Infusion Due to Sterility Concerns

    Infusion Options, Inc. is recalling Diphenhydramine 25 mg/50 mL NS infusions in New York due to a lack of assurance of sterility.

    Product
    DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1788-2019·2019-08-21

    Iron Sucrose Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Iron Sucrose 200 mg/100 mL IV products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1812-2019·2019-08-21

    Infusion Options Recalls IV Fluids Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific IV fluid products in New York due to a lack of assurance of sterility.

    Product
    Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium Sulfate 2 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1819-2019·2019-08-21

    Ferric Carboxymaltose Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Ferric Carboxymaltose 750mg/50ml NS IVPB due to a lack of assurance of sterility. The product was distributed in New York.

    Product
    FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1801-2019·2019-08-21

    Pembrolizumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Pembrolizumab 200 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1807-2019·2019-08-21

    Infusion Options Recalls Ramucirumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific Ramucirumab infusion products in New York due to a lack of assurance of sterility.

    Product
    RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1789-2019·2019-08-21

    Infusion Options Recalls Leucovorin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Leucovorin intravenous infusion bags due to a lack of assurance of sterility. The products were distributed in New York.

    Product
    LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1802-2019·2019-08-21

    Panitumumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Panitumumab 400 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1757-2019·2019-08-21

    Infusion Options Recalls Carfilzomib Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various strengths of Carfilzomib infusions in New York due to a lack of assurance of sterility.

    Product
    CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 ML D5W IVPB; CARFILZOMIB 45 MG IN 50 ML D5W IVPB; CARFILZOMIB 46.2 MG IN 50 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state