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.

976–1000 of 1691

  • HighFDA (Devices)·Z-2753-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 1,528,000 units of 3ml syringes because several lots did not receive the specified dose of irradiation required to meet sterility standards.

    Product
    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2750-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 340,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.

    Product
    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0953-2017·2017-07-19

    Advanced Pharma Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling QUELICIN (Succinylcholine Chloride) Injection due to a lack of assurance of sterility. The recall affects 2,350 units distributed nationwide.

    Product
    QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0946-2017·2017-07-12

    Fagron Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    Fagron Compounding Services is voluntarily recalling 1,056 syringes of Succinylcholine Chloride because the company cannot ensure the product is sterile.

    Product
    Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 72,575 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2529-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues

    Creganna Medical Devices is recalling 85 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0888-2017·2017-06-14

    MedPark Pharmacy Recalls Methylcobalamin Injection Vials Due to Sterility Concerns

    MedPark Pharmacy is recalling methylcobalamin 1mg/1mL injection vials because the company cannot ensure the product is sterile. The affected lot was distributed to a patient in Maryland.

    Product
    methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0875-2017·2017-06-07

    SCA Pharmaceuticals Recalls Hydrocodone Injectable Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 87 bags of Hydromorphone HCL injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2176-2017·2017-06-07

    AbbVie Recalls 673 PEG Kits Due to Sterility Concerns

    AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.

    Product
    AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0856-2017·2017-05-31

    Sato Pharmaceutical Recalls DORAMA-NEO Eye Wash Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 14,325 bottles of DORAMA-NEO eye wash because the manufacturer failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0855-2017·2017-05-31

    Sato Clear Eye Drops Recalled for Sterility Assurance Failure

    Sato Pharmaceutical is recalling Sato Clear eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0854-2017·2017-05-31

    Sato Pharmaceutical Recalls Optic Splash Eye Drops Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 10,130 bottles of Optic Splash eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2130-2017·2017-05-31

    Teleflex Recalls Infant Catheter Connectors Due to Sterility Concerns

    Teleflex Medical is recalling 19,043 units of INFANT 20/BX sterile catheter connectors. The recall was initiated voluntarily due to a lack of reason for recall in the source text.

    Product
    INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0753-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.

    Product
    TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0733-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded PGE1/CPZ Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ due to lack of assurance of sterility. The recall affects 2 vials distributed in the U.S., Australia, and Canada.

    Product
    PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Glutathione Inhalation Solution

    Key Pharmacy and Compounding Center is recalling sterile compounded glutathione inhalation solution due to lack of assurance of sterility.

    Product
    GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0751-2017·2017-05-24

    Key Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX injection due to a lack of assurance of sterility.

    Product
    TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0743-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 20/30/0.5 injection vials due to a lack of assurance of sterility.

    Product
    TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0713-2017·2017-05-24

    Key Pharmacy Recalls CO-Q-10 Oil Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling CO-Q-10 Oil Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0735-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.

    Product
    TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0707-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF injections because the firm cannot assure the products are sterile.

    Product
    5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0739-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling a specific lot of TRI MIX injection due to a lack of assurance of sterility.

    Product
    TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2017·2017-05-24

    FDA Recalls Key Pharmacy Compounded Sterile Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0750-2017·2017-05-24

    FDA Recalls Key Pharmacy Compounded Sterile Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX sterile compounded injections due to a lack of assurance of sterility. The affected vials were distributed in the U.S., Australia, and Canada.

    Product
    TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0748-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/4 injection vials because the firm cannot assure the sterility of the product.

    Product
    TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide