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.

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.

601–625 of 1423

  • SevereFDA (Drugs)·D-0274-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC/B12/Carnitine Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC/B12(C)/Carnitine injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2020·2019-11-13

    Red Mountain Compounding Recalls S-DMSO Eye Drops Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-DMSO 6.25% ophthalmic solution because the product lacks assurance of sterility.

    Product
    S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Dexpantenol Injection Vials

    Red Mountain Compounding Pharmacy is recalling S-Dexpantenol injection vials due to a lack of assurance of sterility.

    Product
    S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2020·2019-11-13

    Red Mountain Compounding Recalls Sterility-Compromised CYP/PROP Vials

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in sesame oil due to a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2020·2019-11-13

    Red Mountain Compounding Recalls S-HCG Injections Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling 81 vials of S-HCG 1200U/ML injection solution because the product lacks assurance of sterility.

    Product
    S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2020·2019-11-13

    Red Mountain Compounding Recalls S-Testosterone Ultra Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Testosterone Ultra 250mg/ml vials because the product lacks assurance of sterility.

    Product
    S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2020·2019-11-13

    Red Mountain Compounding Recalls S-Ascorbic/Glutathione Ophthalmic Solution

    Red Mountain Compounding Pharmacy is recalling S-Ascorbic/Glutathione 1.25/1.25% Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2020·2019-11-13

    Red Mountain Compounding Recalls S-Procaine HCL 2% Buffered Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Procaine HCL 2% Buffered due to a lack of assurance of sterility. The affected prescription products were distributed nationwide.

    Product
    S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0160-2020·2019-11-06

    Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns

    Innoveix Pharmaceuticals is recalling 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units due to a lack of sterility assurance.

    Product
    Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0159-2020·2019-11-06

    Innoveix Recalls Lyophilized Sermorelin Injection Due to Sterility Concerns

    Innoveix Pharmaceuticals is recalling 1,747 vials of compounded Sermorelin injection because the product lacks sterility assurance.

    Product
    Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0158-2020·2019-11-06

    Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns

    Innoveix Pharmaceuticals is recalling 413 vials of Lyophilized Human Chorionic Gonadotropin 5,000 USP Units due to a lack of sterility assurance.

    Product
    Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0157-2020·2019-11-06

    Innoveix Recalls Lyophilized Chorionic Gonadotropin Due to Sterility Concerns

    Innoveix Pharmaceuticals is recalling 3,905 vials of Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection due to a lack of sterility assurance.

    Product
    Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0152-2020·2019-10-30

    Avella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 808 droptainers of Povidone Iodine, 5% Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0150-2020·2019-10-30

    Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns

    Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2020·2019-10-30

    IrriMAX Recalls Irrisept Wound Debridement System Due to Seal Defect

    IrriMAX Corporation is recalling 1,031 cases of Irrisept Wound Debridement and Cleansing Systems because a potential defect in the sterile pouch seal may result in a lack of sterility assurance.

    Product
    Irrisept Wound Debridement and Cleansing System. 12 units per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0065-2020·2019-10-09

    KRS Global Biotechnology Recalls Ketamine Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 11,733 syringes of Ketamine in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 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 33487. NDC 3321678093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2020·2019-10-09

    FDA Recalls Hyaluronidase Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling 928 vials of Hyaluronidase Ophthalmic Injection because the product lacks assurance of sterility.

    Product
    Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0073-2020·2019-10-09

    KRS Global Biotechnology Recalls Methylcobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,189 vials of Methylcobalamin injection nationwide due to a lack of assurance of sterility.

    Product
    Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0030-2020·2019-10-09

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

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/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-0108-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 649 droptainers of a sterile ophthalmic solution because the company cannot ensure the product's sterility.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0064-2020·2019-10-09

    FDA Recalls Ketamine Syringes Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 1,044 syringes of Ketamine in 0.9% Sodium Chloride because the product lacks assurance of sterility.

    Product
    Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0095-2020·2019-10-09

    FDA Recalls Sermorelin Vials Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 647 vials of Sermorelin and related peptides because the company cannot ensure the products are sterile.

    Product
    Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816
    Category
    Drug
    Distribution
    Distributed nationwide