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.

1151–1175 of 1691

  • SevereFDA (Drugs)·D-0569-2016·2016-01-27

    Amerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns

    Amerita Specialty Infusion Services is recalling specific lots of compounded Baclofen syringes because the FDA identified a lack of assurance of sterility.

    Product
    Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0585-2016·2016-01-27

    Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure

    Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0556-2016·2016-01-06

    Walgreens Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection in Texas due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0550-2016·2016-01-06

    Clindamycin Injection Bags Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling Clindamycin injection Accuflo bags in Texas due to a lack of assurance of sterility.

    Product
    Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0544-2016·2016-01-06

    Walgreens Recalls Sodium Ascorbate Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling compounded Sodium Ascorbate (Vitamin C) syringes in Texas due to a lack of assurance of sterility.

    Product
    Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0551-2016·2016-01-06

    Walgreens Recalls Nafcillin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 7 bags of Nafcillin 12 gm in NS 500 mL due to a lack of assurance of sterility. The product was distributed in Texas.

    Product
    Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0404-2016·2015-12-16

    Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns

    Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.

    Product
    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0424-2016·2015-12-09

    Western Drug Recalls Cantharidin 0.7% Solution Due to Sterility Concerns

    Western Drug is recalling Cantharidin 0.7% Solution because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0417-2016·2015-12-09

    Western Drug Recalls Alcohol and Bupivicaine Solution Due to Sterility Concerns

    Western Drug is recalling Alcohol 4%/Bupivicaine 0.5% solution because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2016·2015-12-09

    Western Drug Boric Acid Ear Drops Recalled for Sterility Concerns

    Western Drug is recalling Boric Acid 1% Ear Drops due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2016·2015-12-09

    Western Drug Recalls Testosterone Injection Due to Sterility Concerns

    Western Drug is recalling 75 containers of Test Cyp/Test Prop 1:1 Injection due to a lack of assurance of sterility.

    Product
    Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0430-2016·2015-12-09

    Western Drug Recalls Heparin Sodium Injection Due to Sterility Concerns

    Western Drug is recalling Heparin Sodium 30,000U/30ML Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0395-2016·2015-12-09

    Western Drug Recalls Ace-Promazine Injection Due to Sterility Concerns

    Western Drug is recalling Ace-Promazine 10 mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2016·2015-12-09

    Western Drug Recalls Tacrolimus Eye Drops Due to Sterility Concerns

    Western Drug is recalling two containers of Tacrolimus 0.02% Opth Sol due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2016·2015-12-09

    Western Drug Recalls Super B Complex Injections Due to Sterility Concerns

    Western Drug is recalling four containers of Super B Complex w/Cyano Inj due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0444-2016·2015-12-09

    Western Drug Recalls Procaine HCl Injection Due to Sterility Concerns

    Western Drug is recalling Procaine HCl Injection 1% and 2% because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2016·2015-11-25

    US Compounding Recalls Pilocarpine Ophthalmic Drops Due to Sterility Concerns

    US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted sterility assurance.

    Product
    Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2016·2015-11-25

    US Compounding Recalls L-Cysteine PF Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,706 vials of L-Cysteine PF due to deficient practices that may impact sterility assurance.

    Product
    L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-306-2016·2015-11-25

    Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.

    Product
    HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0256-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-309-2016·2015-11-25

    Essential Wellness Pharma Recalls HCG Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling HCG 3000 Units/mL Injection vials due to poor sterile production practices that compromised sterility assurance.

    Product
    HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-316-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.

    Product
    Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-323-2016·2015-11-25

    Essential Wellness Pharma Recalls QUAD MIX Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling QUAD MIX Injection vials because poor sterile production practices may have compromised the sterility of the finished drugs.

    Product
    QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0240-2016·2015-11-25

    US Compounding Recalls Betamethasone SP Vials Due to Sterility Concerns

    US Compounding Inc is recalling Betamethasone SP vials nationwide because deficient practices may have impacted sterility assurance.

    Product
    Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-331-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise sterility assurance.

    Product
    Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide