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.

1176–1200 of 1691

  • SevereFDA (Drugs)·D-0243-2016·2015-11-25

    US Compounding Recalls Brompheniramine Maleate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 589 vials of Brompheniramine Maleate due to deficient practices that may impact sterility assurance.

    Product
    Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-329-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-320-2016·2015-11-25

    Essential Wellness Pharma Recalls Compounded Progesterone Injections for Sterility Concerns

    Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-336-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX SPECIAL Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX SPECIAL Injection vials because poor sterile production practices created a lack of sterility assurance for the finished drugs.

    Product
    TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2016·2015-11-25

    Downing Labs Recalls Dexpanthenol Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 235 vials of Dexpanthenol Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2016·2015-11-25

    US Compounding Recalls Vitamin D3 Vials Due to Sterility Concerns

    US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil due to deficient practices that may impact sterility assurance.

    Product
    Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0339-2016·2015-11-25

    Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.

    Product
    L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-314-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Injections Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 1 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.

    Product
    Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0254-2016·2015-11-25

    US Compounding Recalls HCG/B12 Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 7,852 vials of HCG/B12 injection nationwide because deficient practices may have impacted sterility assurance.

    Product
    HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-335-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #4 Injection Due to Sterility Concerns

    Kalman Health & Wellness is recalling TRIMIX #4 Injection vials due to poor sterile production practices that compromise sterility assurance.

    Product
    TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2016·2015-11-25

    US Compounding Recalls Vancomycin Ophthalmic Preparations Due to Sterility Concerns

    US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF due to deficient practices that may impact sterility assurance.

    Product
    Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-318-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 30 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.

    Product
    Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2016·2015-11-25

    US Compounding Recalls Zinc Sulfate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 562 vials of Zinc Sulfate 1 mg/mL due to deficient practices that may impact sterility assurance.

    Product
    Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-298-2016·2015-11-25

    Essential Wellness Pharma Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

    Essential Wellness Pharma is recalling Acetylcysteine 10% Ophthalmic Solution due to poor sterile production practices that compromised sterility assurance.

    Product
    Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-304-2016·2015-11-25

    Essential Wellness Pharma Recalls Dual Test Cyp/ena Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2016·2015-11-25

    US Compounding Recalls Dexamethasone Sodium Phosphate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 235 vials of Dexamethasone Sodium Phosphate PF due to deficient practices that may impact sterility assurance.

    Product
    Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0372-2016·2015-11-25

    Downing Labs Recalls Piracetam Injection Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling Piracetam Injection, 200mg/mL, 10mL vials due to a lack of assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2016·2015-11-25

    US Compounding Recalls Neostigmine Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide due to deficient practices that may impact sterility assurance.

    Product
    Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-311-2016·2015-11-25

    Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

    Kalman Health & Wellness is recalling HCG 10,000 Units/mL injections because poor sterile production practices created a lack of sterility assurance.

    Product
    HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2016·2015-11-25

    US Compounding Recalls Medroxyprogesterone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 439 vials of Medroxyprogesterone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-324-2016·2015-11-25

    Sermorelin Injection Recalled Due to Lack of Sterility Assurance

    Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-300-2016·2015-11-25

    Essential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromise sterility assurance.

    Product
    17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-326-2016·2015-11-25

    Essential Wellness Pharma Recalls Sermorelin Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Sermorelin 1000 mcg/mL / LIDO 0.2% Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2016·2015-11-25

    US Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0242-2016·2015-11-25

    US Compounding Recalls Bi-Mix Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 96 vials of Bi-Mix sterile preparations nationwide due to deficient practices that may impact sterility assurance.

    Product
    Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05
    Category
    Drug
    Distribution
    Distributed nationwide