The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 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 1,048 (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.

1226–1250 of 1417

  • SevereFDA (Drugs)·D-0383-2016·2015-11-25

    Downing Labs Recalls MIC Injection Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling MIC w/Methyl B-12 Preserved Injection vials because the company cannot assure the sterility of the product. The recall affects 49 vials distributed nationwide and internationally.

    Product
    MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL 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-0373-2016·2015-11-25

    Downing Labs Recalls Pyridoxine Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling Pyridoxine Injection, 100 mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 280 vials distributed nationwide and internationally.

    Product
    Pyridoxine Injection, 100 mg/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-0348-2016·2015-11-25

    Downing Labs Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Downing Labs is recalling Methylcobalamin Buffered Injectable vials because the company cannot guarantee the product is sterile.

    Product
    Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL 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-0270-2016·2015-11-25

    US Compounding Recalls Morphine PF Vials Due to Sterility Concerns

    US Compounding Inc is recalling 5,919 vials of Morphine PF due to deficient practices that may impact sterility assurance.

    Product
    Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-321-2016·2015-11-25

    Progesterone Injection Recalled for Lack of Sterility Assurance

    Essential Wellness Pharmacy is recalling Progesterone 100 mg/mL injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2016·2015-11-25

    Downing Labs Recalls Glucosamine HCL Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.

    Product
    Glucosamine HCL Injectable, 200mg/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-313-2016·2015-11-25

    Essential Wellness Pharma Recalls LIPO-B Special Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling LIPO-B Special Injection vials because poor sterile production practices created a lack of sterility assurance.

    Product
    LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-332-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #1 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.

    Product
    TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0362-2016·2015-11-25

    Downing Labs Recalls TNPDR Injection Buffered Due to Sterility Concerns

    Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.

    Product
    TNPDR Injection Buffered, 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-0357-2016·2015-11-25

    Downing Labs Recalls EDTA Calcium Disodium Injectable Due to Sterility Concerns

    Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.

    Product
    EDTA Calcium Disodium Injectable, 300mg/mL, 50mL 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-334-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #3 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    TRIMIX #3 (24 mg-1 mg-20 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-0350-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate 50% Injectable, 50mL 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-0371-2016·2015-11-25

    Downing Labs Recalls Folic Acid Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 178 vials of Folic Acid Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed in the US and 17 other countries.

    Product
    Folic Acid Injection, 10mg/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-310-2016·2015-11-25

    Essential Wellness Recalls HCG Injection Vials Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling HCG 5000 Units/mL injection vials because poor production practices raised concerns about the sterility of the compounded drugs.

    Product
    HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-301-2016·2015-11-25

    Essential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling BIMIX INJ 30 mg-1 mg/mL Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-325-2016·2015-11-25

    Essential Wellness Pharma Recalls Sermorelin Injections Due to Sterility Concerns

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

    Product
    Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-305-2016·2015-11-25

    Essential Wellness Pharma Recalls Glycerin Opth Solution Due to Sterility Concerns

    Kalman Health & Wellness is recalling Glycerin Opth Solution because poor sterile production practices may have compromised the sterility of the finished drug.

    Product
    Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-302-2016·2015-11-25

    Essential Wellness Pharma Recalls Cyclosporin Eye Drops Due to Sterility Concerns

    Essential Wellness Pharma is recalling specific lots of Cyclosporin 0.1% Opth Solution because poor sterile production practices created a lack of sterility assurance.

    Product
    Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0140-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 90 mg testosterone pellets because the agency could not ensure the sterile compounded drugs were sterile.

    Product
    TESTOSTERONE, Pellet, 90 mg, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0126-2016·2015-11-04

    FDA Recalls Testosterone Pellets Due to Lack of Sterility Assurance

    The FDA is recalling specific lots of compounded testosterone pellets from Moses Lake Professional Pharmacy because the manufacturer cannot ensure the products are sterile.

    Product
    TESTOSTERONE, Pellet, 106 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0099-2016·2015-11-04

    Moses Lake Pharmacy Recalls Hydroxocobalamine/Methylcobalamine Syringes for Sterility Concerns

    JD & SN Inc. is recalling 5 syringes of Hydroxocobalamine/Methylcobalamine Injectable Solution due to a lack of assurance of sterility.

    Product
    HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE, Injectable Solution, 1.5/1.5 mg/0.25 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Vitamin Injectable Solution

    JD & SN Inc. is recalling compounded vitamin injectable solutions due to a lack of assurance of sterility.

    Product
    CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Moses Lake Professional Pharmacy is recalling Estradiol Pellets because the FDA determined there is a lack of assurance of sterility for the compounded drug.

    Product
    ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns

    JD & SN Inc. is recalling 184 syringes of compounded chorionic gonadotropin nationwide because the FDA could not ensure the product was sterile.

    Product
    CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 200 UNITS/0.2ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2016·2015-11-04

    FDA Recalls Chorionic Gonadotropin/Cyanocobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling 26 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide