The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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 1691

  • SevereFDA (Drugs)·D-0233-2020·2019-11-13

    Red Mountain Compounding Recalls Lidocaine Syringes Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% inhalation solution syringes due to a lack of assurance of sterility.

    Product
    S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2020·2019-11-13

    Red Mountain Compounding Recalls S-Taurine Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Taurine 50mg/ml vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2020·2019-11-13

    Red Mountain Compounding Recalls S-Vit B Complex Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection vials due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-TEST CYP Vials for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TEST CYP 200mg/ml vials nationwide due to a lack of assurance of sterility.

    Product
    S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2020·2019-11-13

    Red Mountain Compounding Recalls S-Atropine Ophthalmic Solution for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Atropine 0.02% ophthalmic solution due to a lack of assurance of sterility. The affected product is a prescription eye drop distributed nationwide.

    Product
    S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0151-2020·2019-10-30

    Nephron Recalls del Nido Cardioplegia Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 1,047 bags of del Nido Cardioplegia Solution because the bags may leak, compromising sterility.

    Product
    del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2020·2019-10-16

    Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns

    Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.

    Product
    LMD IN DEXTROSE — LMD IN DEXTROSE (DEXTRAN 40)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0020-2020·2019-10-09

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

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

    Product
    C-PAPAV/PHENTOL/PGE1 10MG/1MG/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-1883-2019·2019-10-09

    Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.

    Product
    Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2020·2019-10-09

    KRS Global Biotechnology Recalls Alpha Lipoic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 77 vials of Alpha Lipoic Acid for IV use nationwide due to a lack of assurance of sterility.

    Product
    Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2020·2019-10-09

    KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.

    Product
    NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 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 3321678303
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0087-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 228 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.

    Product
    PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0011-2020·2019-10-09

    Colonia Care Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Gentamicin injection because the sterility of the product cannot be guaranteed.

    Product
    C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0023-2020·2019-10-09

    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 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0004-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Albumin 5% Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.

    Product
    C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0117-2020·2019-10-09

    KRS Global Biotechnology Recalls L-Asparaginase Lyophilized Due to Sterility Concerns

    KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.

    Product
    L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0032-2020·2019-10-09

    Colonia Care Pharmacy Recalls Tacrolimus Ophthalmic Suspension Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Tacrolimus 0.03% ophthalmic suspension because the sterility of the product cannot be guaranteed.

    Product
    C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 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-0006-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.02% because the product's sterility cannot be guaranteed.

    Product
    C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0097-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0045-2020·2019-10-09

    KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling L-Carnitine vials because the company cannot ensure the product is sterile. The recall covers 6,447 vials distributed nationwide.

    Product
    L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0107-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 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, FL 33487. NDC 3321678092
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0100-2020·2019-10-09

    Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns

    KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.

    Product
    Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
    Category
    Drug
    Distribution
    Distributed nationwide